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918 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : " BLU-667-1101 BLU-667 2016-004390-41 "
Spécialité : Endocrinologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : À venir

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I
Descriptif

Experimental: BLU-667

Dose Escalation: Multiple doses of BLU-667 for oral administration.
Dose Expansion: Oral dose of BLU-667 as determined during Dose Escalation.

Informations

Cancer du Poumon non à petites cellules,

Cancer de la thyroïde,

localement avancé métastatique : translocation/fusion et mutation RET +

2ème ligne et + selon cohorte

Phase : 1

Promoteur: Blueprint Medicines Corporation
Autre(s) acronyme(s): BLU-667-1101
2016-004390-41
Contact promoteur: Blueprint Medicines

Mail promoteur: studydirector@blueprintmedicines.com
Tel promoteur: 617-714-6707
Coordonnateur: NR
-
Source: Clinical trial.gov 2019

Cet essai dans d'autres annuaires :

Titre :

A Phase 1 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors

Critères d'inclusion :
  1. Diagnosis during dose escalation (Part 1) - Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.

  2. All patients treated at doses > 120 mg per day must have medullary thyroid cancer (MTC), or a RET-altered solid tumor per local assessment of tumor tissue and/or blood.

  3. Diagnosis during dose expansion (Part 2) - All patients (with the exception of Groups 3 and 4) must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local or central testing of tumor or circulating tumor nucleic acid in blood; as detailed below.

  4. Group 1 - patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion previously treated with a platinum-based chemotherapy.

  5. Group 2 - patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion not previously treated with a platinum-based chemotherapy.

  6. Group 3 - patients must have pathologically documented, definitively diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit and was previously treated with cabozantinib and/or vandetanib.

  7. Group 4 - patient must have pathologically documented, definitely diagnosed advanced MTC that has progressed within 14 months prior to the Screening Visit and was not previously treat with cabozantinib and/or vandetanib.

  8. Group 5 -patients must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET fusion previously treated with SOC appropriate for the tumor type and not eligible for any of the other groups.

  9. Group 6 - patients must have a pathologically documented, definitely diagnosed advanced solid tumor with an oncogenic RET fusion or mutation that was previously treated with a selective TKI that inhibits RET

  10. Group 7 - patients must have a pathologically documented, definitively diagnosed advanced solid tumor with an oncogenic RET mutation previously treated with SOC appropriate for the tumor type and not eligible for any of the other groups

  11. Patient must have non-resectable disease that has progressed following standard therapy or has not adequately responded to standard therapy, or the patient must be intolerant to, or the Investigator has determined that treatment with standard therapy is not appropriate, or there must be no accepted standard therapy for their disease.

  12. Patient has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

Critères de non-inclusion :
  1. Patient's cancer has a known primary driver alteration other than RET. For example, NSCLC with a targetable mutation in EGFR, ALK, ROS1 or BRAF; colorectal with an oncogenic KRAS, NRAS, or BRAF mutation.

  2. Patient has any of the following within 14 days prior to the first dose of study drug:

  3. Platelet count < 75 × 10^9/L.

  4. Absolute neutrophil count <1.0 × 10^9/L.

  5. Hemoglobin < 9.0 g/dL (red blood cell transfusion and erythropoietin may be used to reach at least 9.0 g/dL, but must have been administered at least 2 weeks prior to the first dose of study drug.

  6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × the upper limit of normal (ULN) if no hepatic metastases are present; >5 × ULN if hepatic metastases are present.

  7. Total bilirubin > 1.5 × ULN; > 3 × ULN with direct bilirubin > 1.5 × ULN in presence of Gilbert's disease.

  8. Estimated (Cockcroft-Gault formula) or measured creatinine clearance <40 mL/min.

  9. Total serum phosphorus >5.5 mg/dL

  10. QT interval corrected using Fridericia's formula (QTcF) >470 msec or history of prolonged QT syndrome or Torsades de pointes, or familial history of prolonged QT syndrome.

  11. Clinically significant, uncontrolled, cardiovascular disease.

  12. Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.

  13. Clinically symptomatic interstitial lung disease or interstitial pneumonitis including radiation pneumonitis

  14. Patients in Groups 1-5 and 7 (Part 2) previously treated with a selective RET inhibitor

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Hervé Lena - herve.lena@chu-rennes.fr ARCs/IRCs Pneumologie - ide-pneumo-arc@chu-rennes.fr 1 / 5 Oui 28/03/2019
Afficher les détails
Acronyme : " COMBO D5330C00004"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase Ia, Phase Ib
Descriptif

Experimental: Module 1 Part A
Module 1 Part A: ascending doses of AZD6738 in combination with carboplatin AUC5 will be administered to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 1 Part B
Module 1 Part B: patients with advanced lung adenocarcinoma with low expression of ATM will receive AZD6738 and carboplatin, at the dose, frequency and schedule recommended from Module 1 Part A.
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 2 Part A1
Module 2 Part A1: ascending doses of AZD6738 will be administered alone to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) to take into Module 2 Part A2.
Intervention: Drug: Administration of AZD6738

Experimental: Module 2 Part A2
Module 2 Part A2: ascending doses of AZD6738 will be administered in combination with olaparib to patients to define the dose, frequency and schedule of AZD6738 and olaparib to take into Module 2 Part B.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B1
Module 2 Part B1: Patients with second line 'ATM deficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B2
Module 2 part B2: Patients with second line 'ATM proficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B3
Module 2 Part B3: Patient with second or third line breast cancer with BRCA mutations (somatic or germline), excluding HER2 positive breast cancer will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B4
Module Part B4: Patients with second or third line triple negative breast cancer with no known BRCA mutations. This expansion will be enriched for patients with disease harbouring a HRR-related gene mutation (HRRm) will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 3 Part A
Module 3 Part A: cohort escalation of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients to define the dose, frequency and schedule of AZD6738 and MEDI4736 to take into Module 3 Part B.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Experimental: Module 3 Part B
Module 3 Part B: cohort expansions of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients at dose, frequency and schedule from Module 3 Part A.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Informations

ATM deficient, ATM proficient, HER2 negative, Breast, Gastric, Head & Neck, Lung

cancer métastatique

ligne de traitement variable selon les organes

 

12/12/2018
B3 : cancer du sein HER2 négatif avec mutation BRCA1 ou BRCA2 somatique ou germinale, en 2ème et 3ème ligne : Fermé
B4 : cancer du sein triple négatif sans mutation BRCA1 ou BRAC2 identifiée, en 2ème ou 3ème ligne : Ouvert

 

Phase: 1,1b,

Promoteur: AstraZeneca
Autre(s) acronyme(s): D5330C00004
Contact promoteur: AstraZeneca Clinical Study Information Center
AstraZeneca Cancer Study Locator Service

-
Source: Clinical trials.gov le 02/08/2018"

Cet essai dans d'autres annuaires :

Titre :

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies

Critères d'inclusion :
  1. "Aged at least 18

  2. The presence of a solid malignant tumour that is not considered appropriate for further standard treatment

  3. Module 1 and 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan

  4. Module 1 Part B Study expansion: second line lung adenocarcinoma with ATM deficient tumours.

  5. Module 2 Part B All - No previous treatment with PARP inhibitor.

  6. Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours

  7. Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours

  8. Module2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer

  9. Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC) Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma"

Critères de non-inclusion :
  1. "A diagnosis of ataxia telangiectasia

  2. Prior exposure to an ATR inhibitor

  3. Bad reaction to AZD6738

  4. Module 1: Contra-indicated for treatment with carboplatin

  5. Module 2: Contra-indicated for treatment with olaparib

  6. Module 3: Contra-indicated for treatment with MEDI4736"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest Dr CAMPONE Mario - - / Oui 11/09/2018
Afficher les détails
Acronyme : " METRIC CDX-011 Glembatumumab"
Spécialité : Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Non

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Active Comparator: Capecitabine
Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Drug: Capecitabine

Experimental: Drug: CDX-011
CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.

Informations


Cancer du sein triple négatif surexprimant gpNMB 

1ère ou 2ème ligne métastatique

A progression, ayant recu des anthracyclines

"Phase: 2

Promoteur: Celldex Therapeutics
Autre(s) acronyme(s): CDX-011
Glembatumumab
Contact promoteur: Celldex Therapeutics
-
Source: Clinicaltrials.org 09/10/2017"

Cet essai dans d'autres annuaires :

Titre :

"A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study) "

Critères d'inclusion :

Among other criteria, patients must meet all of the following conditions to be eligible for the study:

  1. Diagnosed with metastatic (i.e., cancer that has spread) TNBC

    - minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by             immunohistochemistry

    - HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell

  2. Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.

  3. Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.

  4. Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.

  5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).

  6. ECOG performance status of 0 - 1.

  7. Adequate bone marrow, liver and renal function.

Critères de non-inclusion :
  1. Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.

  2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.

  3. Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.

  4. Significant cardiovascular disease.

  5. Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.

  6. Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.

  7. Chronic use of systemic corticosteroids.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Mercier-Blas - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com / Non 09/10/2017
Afficher les détails
Acronyme : "2017-A02058-45 PHRC-K16-164 STEREOPOSTOP"
Spécialité : ORL
Traitement : Traitement adjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: postoperative SBRT
SBRT consists of a total dose of 36 Gy in 6 fractions over 11-13 days
Intervention: Radiation: postoperative hypofractionated stereotactic radiotherapy

Informations

Carcinome épidermoide, stade 1, stade 2

Oropharynx, cavité buccale

Adjuvant

Phase: 2

Promoteur: Centre Jean Perrin
Autre(s) acronyme(s): PHRC-K16-164
STEREOPOSTOP
Contact promoteur: Julian BIAU
Mail promoteur: julian.biau@clermont.unicancer.fr
Tel promoteur: 33473278089

-
Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Titre :

A Multicenter Prospective Phase II Study of Postoperative Hypofractionated Stereotactic Body Radiotherapy (SBRT) in the Treatment of Early Stage Oropharyngeal and Oral Cavity Cancers With High Risk Margins

Critères d'inclusion :
  1. Operated squamous cell carcinoma of oral cavity (lips excepted) or oropharynx

  2. pT1 or pT2 ((UICC 7th edition 2009)

  3. Indication of postoperative tumor site irradiation (retained in multidisciplinary tumor board) with at least one of the following criteria :

    positive R1 margin (re-resection not proposed)

    close margin < 5 mm (re-resection not proposed)

    Margin estimated at risk, with uncertain pathological margin (re-resection not proposed)

  4. N0 after surgical management of the neck (neck dissection or sentinel lymph node biopsy) or pN1 without extracapsular extension (carcinological neck dissection)

  5. Age ≥ 18 years

  6. ECOG status ≤ 2

  7. Written signed informed consent before any specific procedure of the protocol

  8. Affiliation to a social security scheme or beneficiary of such a scheme

Critères de non-inclusion :
  1. Other histology than squamous cell carcinoma

  2. pT3 or pT4

  3. pT2>3cm and R1 with concurrent chemoradiotherapy decided in multidisciplinary tumor board

  4. Lymphovascular invasion justifying neck irradiation

  5. Neck irradiation decided in multidisciplinary tumor board

  6. Lack of at least one of the following elements :

    pre-operative medical imaging (CT scan or MRI)

    endoscopy report

    surgery report

    pathological report

  7. Prior radiotherapy to the head and neck area

  8. Distant metastasis

  9. Pregnant or nursing (lactating) woman

  10. women or men of childbearing age not taking adequate contraceptive measure

  11. participation in another investigational study within 4 weeks prior to inclusion

  12. History of other malignancy within 5 years prior enrollment except for basal cell carcinoma of the skin or carcinoma in situ of the cervix

  13. Persons deprived of their liberty, under guardianship or curatorship, or unable to follow the trial for geographical, social or psychological reasons

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Chamois - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com NC / NC Oui 21/02/2019
Afficher les détails
Acronyme : "205801 GSK205801 Ombrelle"
Spécialité : Pneumologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Subjects receiving GSK3359609 (ICOS Agonist) + Docetaxel
Subjects will receive the combination once every 3 weeks as an IV infusion. Subjects receiving docetaxel will be premedicated according to approved product label or standard practice.

Drug: Docetaxel
Drug: GSK3359609 (ICOS Agonist)
Active Comparator: Subjects receiving Docetaxel
Subjects will receive docetaxel once in every 3 weeks as an intravenous infusion.

Informations

Cancer du poumon non à petites cellules (CPNPC), avancé ayant progressé à un précédent traitement anti-PD(1) et aux chimiothérapies à base de sel de platine

2ème ligne et +

Phase: 2

Promoteur: GSK
Autre(s) acronyme(s): Ombrelle
Contact promoteur: US GSK Clinical Trials Call Center

Mail promoteur: GSKClinicalSupportHD@gsk.com
Tel promoteur: 877-379-3718



Cet essai dans d'autres annuaires :

Titre :

A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants

Critères d'inclusion :
  1. Subjects capable of giving signed informed consent/assent.

  2. Male or female, aged 18 years or older at the time consent is obtained.

  3. Subjects with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and: a. Documented disease progression (for example, based on radiographic imaging) during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IV or metastatic disease: i. A maximum of 1 line of platinum-containing chemotherapy regimen in the metastatic setting, and ii. A maximum of 1 line of PD(L)1 monoclonal antibody (mAb) containing regimen. b. Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration. Participants with this alteration could have received up to 3 lines of systemic anticancer therapy.

  4. Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.

  5. ECOG PS score of 0 or 1.

  6. A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.

  7. Adequate organ function.

  8. A male subject must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.

  9. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply: a) Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.

Critères de non-inclusion :
  1. Subjects who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment): a. Docetaxel at any time. b. Any of the investigational agents being tested in the current study, including experimental ICOS agonist. c. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered. d. Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.

  2. Received >=3 prior lines of therapy for NSCLC, including subjects with BRAF molecular alternations.

  3. Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years.

  4. Central nervous system (CNS) metastases, with the following exception: Subjects with asymptomatic CNS metastases who are clinically stable and have no requirement for steroids for at least 14 days prior to first dose of study treatment.

  5. Major surgery <= 28 days of first dose of study treatment.

  6. Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.

  7. Receiving systemic steroids (>=10 milligram [mg] oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.

  8. Prior allogeneic/autologous bone marrow or solid organ transplantation.

  9. Receipt of any live vaccine within 30 days prior to first dose of study treatment.

  10. Toxicity from previous anticancer treatment that includes: a. >= Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation. b. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2).

  11. History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past-pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.

  12. Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.

  13. Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.

  14. History or evidence of cardiac abnormalities within the 6 months prior to enrollment.

  15. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.

  16. Active infection requiring systemic therapy.

  17. Subjects with known human immunodeficiency virus infection, or positive test for hepatitis B active infection (presence of hepatitis B surface antigen), or hepatitis C active infection.

  18. Subjects with history of severe hypersensitivity to monoclonal antibodies or hypersensitivity to ingredients used in the formulation of docetaxel.

  19. Subjects requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome 3A4 (CYP3A4) enzymes.

  20. Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.

  21. Pregnant or lactating female subjects.

  22. Subject is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES CHU Pneumologie Dr BENNOUNA - CORVAISIER Murielle - NC / NC Oui 23/05/2019
Afficher les détails
Acronyme : "2102-HEM-101 FT-2102 Forma FT-2102-HEM-101"
Spécialité : Hématologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

Experimental: PH1 Dose Escalation & Expansion FT-2102
Intervention: Drug: FT-2102


Experimental: PH1 Esc. and Exp. FT-2102+Azacitidine
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH1 Esc. and Exp. FT-2102+Cytarabine
Interventions:
Drug: FT-2102
Drug: Cytarabine


Experimental: PH2 Cohort 1 FT-2102 Single Agent
At the completion of Phase 1, Phase 2 Cohort 1 will commence enrollment wherein patients with relapsed or refractory (R/R) AML will be treated with the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 2 FT-2102 Single Agent
In Phase 2 Cohort 2, patients with AML/ MDS in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after cytotoxic-containing induction therapy with residual IDH-R132 mutation will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 3 FT-2102 Single Agent
In Phase 2 Cohort 3, patients with R/R AML/MDS, previously treated with an IDH1 inhibitor will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 4 FT-2102+Azacitidine
In Phase 2 Cohort 4, patients with R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 5 FT-2102+Azacitidine
In Phase 2 Cohort 5, patients with R/R AML/MDS that have inadequately responded or have progressed immediately proceeding hypomethylating therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 6 FT-2102+Azacitidine
In Phase 2 Cohort 6, patients with R/R AML/MDS that have been previously treated with single-agent IDH1 inhibitor therapy as their last therapy prior to study enrollment will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine

Informations

Leucémie myéloïde aiguë ou de syndrome myélodysplasique

mutation IDH1

récidivant ou réfractaire

2ème ligne ou +

Phase: 1,2

Promoteur: NR
Acronymes: 2102-HEM-101 FT-2102
Promoteur : Forma FT-2102-HEM-101

Source: Clinical trial.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

Critères d'inclusion :
  1. Pathologically proven acute myeloid leukemia (AML) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.

  2. Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site

  3. Good performance status

  4. Good kidney and liver function

Critères de non-inclusion :
  1. Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy

  2. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias

  3. Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication

  4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therap

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Nimubona - - 0 / 0 Oui 29/11/2018
Afficher les détails
Acronyme : "29BRC18-0005 VinMetAtezo NCT03801304"
Spécialité : Pneumologie
Traitement : Chimiothérapie
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Atezolizumab associated with vinorelbine

Atezolizumab will be administered with IV infusions. The first one will be a 60-min IV infusion; the subsequent infusions will last 30 minutes when well-tolerated at the dose of 1200 mg on day 1 of each 21-day cycle.
Vinorelbine capsules are taken orally on days 1, 3 and 5 of each week of the 21-day cycle. Vinorelbine will be administered at the dose of 40 mg per day on days 1, 3 and 5 of each week of the 21-day cycle. In case of toxicity, the dose will be decreased to 30 mg.

Informations

Cancer des bronches non à petites cellules (CBNPC)

2ème ligne, récurrent, localement avancé ou métastatique

Phase: 2

Promoteur: University Hospital, Brest
Autre(s) acronyme(s): VinMetAtezo
Contact promoteur: Alain VERGNENEGRE, PUPH
Contact: Sophie LECANUET

Mail promoteur: alain.vergnenegre@unilim.fr
sophie.lecanuet.pro@gmail.com
Tel promoteur: 555056629 ext +33
617987516 ext +33

-
Source: Clinical Trials 2019

Cet essai dans d'autres annuaires :

Titre :

Open Label Phase II Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer

Critères d'inclusion :
  1. Histologically confirmed NSCLC;

  2. Locally advanced and/or metastatic stage IV NSCLC (according to American Joint Committee on Cancers) or recurrent NSCLC);

  3. Patients without activating EGFR mutation or ALK rearrangement and ROS1 fusions.

  4. Subject has provided a formalin-fixed tumor-tissue sample of a tumor-lesion biopsy, either at the time of or after metastatic disease was diagnosed AND from a site not previously irradiated to assess for PDL1 status. Archived tissue may be acceptable;

  5. Patients must have a measurable lesion (RECIST V1.1);

  6. Progressive disease after first-line platinum-doublet-based chemotherapy according to RECIST V.1.1;

  7. Age ≥18 years, either sex;

  8. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;

  9. Life expectancy exceeds 12 weeks;

  10. No history of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin;

  11. Adequate organ function, demonstrated by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin <1.5 × normal (N), Alanine aminotransferase and Aspartate aminotransferase <2.5 × N or <5 × N if liver metastasis is present;

  12. Normal renal function (calculated creatinine clearance ≥45 mL/min);

  13. Normal calcemia;

  14. Normal hematological function (polynuclear neutrophils >1.5 G/L, platelets >100 G/L);

  15. Women of child-bearing potential must use effective contraception;

  16. Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment;

  17. Written informed consent to participate in the study

  18. Patient with social insurance

Critères de non-inclusion :
  1. ECOG PS >2;

  2. Known hypersensitivity to immunotherapy;

  3. Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer;

  4. Tumor harbors EGFR-sensitizing (activating) mutations or ALK translocations or ROS1 fusions and that justify treatment with targeted therapy ;

  5. Chemotherapy, hormonotherapy, immunotherapy or tyrosine-kinase inhibitors within the past 4 weeks prior to treatment with the trial drug;

  6. Radiotherapy (except bone or brain) within the past 3 months prior to baseline imaging;

  7. Medical contraindication to oral vinorelbine;

  8. Persistence of clinical adverse events related to prior treatment;

  9. Active brain metastases (e.g. stable for <4 weeks, no adequate previous radiotherapy, symptomatic, requiring anticonvulsants; dexamethasone will be allowed if administered at a stable dose <10 mg/day for at least 1 month before randomization);

  10. Concurrent radiotherapy, except for palliative bone irradiation.

  11. Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction <12 months before study entry);

  12. Active or prior documented autoimmune or inflammatory disorders;

  13. Active B hepatitis, HIV infection …;

  14. Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial;

  15. Grade-3 peripheral neuropathy;

  16. Uncontrolled infection;

  17. Interstitial lung disease or pneumonitis requiring steroid management;

  18. Corticosteroid therapy exceeding 10 mg/day;

  19. Other severe organic disorders not allowing inclusion in the trial;

  20. Malabsorption syndrome;

  21. Pregnancy or breast-feeding;

  22. Follow-up not possible; and incarcerated or institutionalized patients.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Hervé Lena - herve.lena@chu-rennes.fr ARCs/IRCs Pneumologie - ide-pneumo-arc@chu-rennes.fr NC / 3 Oui 29/03/2019
Afficher les détails
Acronyme : "7902-005 NCT03797326 2018-003747-37 MK-7902-005 E7080-G000-224 LEAP-005"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: Pembrolizumab + Lenvatinib

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).

Informations

Tumeurs solides métastatiques, incurables, non réséquables

Cancer du sein triple neg, cancer de l'ovaire, Cancer Gastrique, Cancer colorectal, Glioblastome, Cancer des voies biliairs

Lignes variables selon l'organe

Phase: 2

Promoteur: Merck Sharp & Dohme Corp.

Autre(s) acronyme(s): NCT03797326

2018-003747-37
MK-7902-005
E7080-G000-224
LEAP-005
Contact promoteur: Merck Sharp & Dohme Corp.
Mail promoteur: Trialsites@merck.com
Tel promoteur: 1-888-577-8839


Source: Clinical Trial 2019

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)

Critères d'inclusion :
  1. Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer: non-microsatellite instability-High/proficient mismatch repair (MSI-H/pMMR) tumor, GBM, BTC: intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater

  2. Must have progressed on or since the last treatment

  3. Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR

  4. Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

  5. Male participants agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment, and refrain from donating sperm during this period

  6. Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days after the last dose of study treatment

  7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days of study treatment initiation

  8. Has adequate organ function

    For Triple Negative Breast Cancer Participants:

  9. Has received one or 2 prior lines of therapy

  10. Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)

    For Ovarian Cancer Participants:

  11. - Has received 3 prior lines of therapy

    For Gastric Cancer Participants:

  12. - Has received 2 prior lines of therapy

    For Colorectal Cancer Participants:

  13. Has received 2 prior lines of therapy

  14. Has a locally determined non-MSI-H/pMMR tumor

    For GBM Participants:

  15. Has failed initial systemic therapy for newly diagnosed GBM

  16. Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines

  17. Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable

  18. Has histologically confirmed World Health Organization (WHO) Grade IV GBM

    For Biliary Tract Cancer Participants:

  19. Has received 1 prior line of therapy

  20. Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

Critères de non-inclusion :
  1. Has presence of gastrointestinal condition including malabsorption that might affect the absorption of lenvatinib

  2. Radiographic evidence of major blood vessel invasion/infiltration

  3. Clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment

  4. Has significant cardiovascular impairment within 12 months of the first dose of study treatment: such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability

  5. Has a history of arterial thromboembolism within 12 months of start of study treatment

  6. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

  7. Serious nonhealing wound, ulcer or bone fracture

  8. Biologic response modifiers (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry.

  9. Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])

  10. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 times the half-life time, whichever is shorter prior to study treatment start

  11. If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment

  12. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease

  13. Has received a live vaccine within 30 days prior to the first dose of study treatment

  14. Known intolerance to study treatment (or any of the excipients)

  15. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

  16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment

  17. Has known active CNS metastases and/or carcinomatous meningitis

  18. Has tumors involving the brain stem

  19. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

  20. Has an active autoimmune disease that has required systemic treatment in past 2 years

  21. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

  22. Has an active infection requiring systemic therapy

  23. Has a known history of human immunodeficiency virus (HIV) infection

  24. Has a known history of hepatitis B or known active hepatitis C virus infection

  25. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

  26. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment

  27. Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection)

    For Colorectal Cancer Participants:

  28. - Has MSI-H/dMMR disease

  29. For GBM Participants:

  30. Has carcinomatous meningitis

  31. Has recurrent tumor greater than 6 cm in maximum diameter

  32. Has tumor primarily localized to the brainstem or spinal cord

  33. Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease

  34. Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest SENELLART Helene - PARERE Adèle - NC / NC Oui 26/04/2019
Afficher les détails
Acronyme : "AP32788-15-101 TAKEDA TAK-788 U1111-1217-7205"
Spécialité : Pneumologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : À venir

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

Experimental: Dose Escalation Cohort
TAK-788 treatment for participants with advanced NSCLC.

Experimental: Expansion Cohort 1
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions, who have either not received or not shown an objective response to an EGFR tyrosine kinase inhibitors (TKI), and who have no active, measurable central nervous system (CNS) metastases.

Experimental: Expansion Cohort 2
TAK-788 treatment for NSCLC participants with HER2 exon 20 activating insertions or point mutations and no active, measurable CNS metastases.

Experimental: Expansion Cohort 3
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions or HER2 exon 20 activating insertions or point mutations and active, measurable CNS metastases.

Experimental: Expansion Cohort 4
TAK-788 treatment for NSCLC participants with other targets against which TAK-788 is active (examples include EGFR exon 19 deletions or exon 21 substitutions [with or without T790M mutations] and other uncommon EGFR activating mutations), with or without active, measurable CNS metastases.

Experimental: Expansion Cohort 5
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an objective response to an EGFR TKI and subsequently progressed, with or without active, measurable CNS metastases.

Experimental: Expansion Cohort 6
TAK-788 treatment NSCLC participants with EGFR exon 20 activating insertions, who have not received prior systemic anticancer treatment for locally advanced or metastatic disease, with or without active, measurable CNS metastases

Experimental: Expansion Cohort 7
TAK-788 treatment for participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active, with or without active CNS metastases.

Experimental: Extension Cohort
TAK-788 treatment for participants with previously treated locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations.

Informations

Cancer du poumon non à petites cellules, localement avancé, métastatique

mutation - insertion HER2 ou EGRF selon les cohortes 

2ème ligne et +

Phase: 1,2

Promoteur: Millennium Pharmaceuticals, Inc/TAKEDA
Autre(s) acronyme(s): AP32788-15-101 TAKEDA
TAK-788
Contact promoteur: Takeda Study Registration Call Center

Mail promoteur: globaloncologymedinfo@takeda.co
Tel promoteur: 1-866-835-2233
Coordonnateur: NR
-
Source: Clinical trials.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer

Critères d'inclusion :

General Inclusion Criteria (all cohorts: dose escalation and expansion):

  1. Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC (Stage IIIB or IV) or other solid tumors. For all cohorts except Expansion Cohort 7, the locally advanced or metastatic disease is NSCLC. For Expansion Cohort 7, the locally advanced or metastatic disease is any solid tumor other than NSCLC

  2. Must have sufficient tumor tissue available for analysis.

  3. Must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1.

  4. Male or female participants greater than or equal to (>=) 18 years old. For participants in Japan, aged >=20 years.

  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

  6. Minimum life expectancy of 3 months or more.

  7. Adequate organ function at baseline.

  8. Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected (Fridericia) (QTcF) of less than or equal to (<=) 450 millisecond (ms) in males or <=470 ms in females.

  9. Willingness and ability to comply with scheduled visits and study procedures.

Part 1: Dose Escalation Cohort Specific Inclusion Criteria:

  1. 1. Refractory to standard available therapies.

Part 2: Expansion Cohort 1 Specific Inclusion Criteria:

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.

  2. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

  3. Prior treatment with an EGFR TKI is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician.

Expansion Cohort 2 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test:

           - A HER2 exon 20 insertion;

           - An activating point mutation in HER2.

  1. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

  2. Prior treatment with a pan-HER TKI (example, afatinib, neratinib, or dacomitinib) is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician.

Part 2: Expansion Cohort 3 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test:

           - An EGFR exon 20 insertion;

            - A HER2 exon 20 insertion;

            - An activating point mutation in HER2.

  1. Previously treated with one or more regimen of systemic therapy for locally advanced or metastatic disease.

  2. For participants with an EGFR exon 20 insertion: prior treatment with an EGFR TKI is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.

  3. For participants with a HER2 exon 20 insertion or HER2 activating point mutation: prior treatment with a pan-HER TKI (example, afatinib, neratinib, or dacomitinib) is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.

  4. Have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions.

  5. Have at least one target (that is, measurable) intracranial CNS lesion (>=10 millimeter [mm] in longest diameter by contrast enhanced magnetic resonance imaging [MRI]).

Part 2: Expansion Cohort 4 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test: an activating mutation in EGFR including exon 19 deletions or exon 21 L858R substitution (with or without T790M), or an uncommon activating mutation other than exon 20 insertion including, but not limited to, G719X (where X is any other amino acid), S768I, L861Q, or L861R.

  2. Treatment naive for locally advanced or metastatic disease or previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

  3. Have or do not have active (untreated or progressing) CNS metastases.

Part 2: Expansion Cohort 5 Specific Inclusion Criteria:

NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an objective response to an EGFR TKI and subsequently progressed, with or without active, measurable CNS metastases.

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.

  2. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

  3. Previously showed an objective response to an EGFR TKI and subsequently progressed as assessed by the investigator or treating physician.

  4. Have or do not have active (untreated or progressing) CNS metastases.

Part 2: Expansion Cohort 6 Specific Inclusion Criteria:

NSCLC participants with EGFR exon 20 activating insertions, who have not received prior systemic anticancer treatment for locally advanced or metastatic disease, with or without active, measurable CNS metastases.

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.

  2. No prior systemic treatment for locally advanced or metastatic disease.

  3. Have or do not have active (untreated or progressing) CNS metastases.

Part 2: Expansion Cohort 7 Specific Inclusion Criteria:

Participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active, with or without active, measurable CNS metastases.

  1. Have a solid tumor that is not NSCLC and that is refractory to standard therapy.

  2. Have EGFR or HER2 mutations, documented by a local test.

  3. Have or do not have active (untreated or progressing) CNS metastases.

Part 3: Extension Cohort Specific Inclusion Criteria:

  1. Have a documented EGFR in-frame exon 20 insertion by a local test and sufficient tumor tissue available for central analysis.

  2. Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days prior to the first dose of TAK-788.

  3. Must have received at least 1 prior line of therapy for locally advanced or metastatic disease and no more than 2 regimens of systemic anticancer chemotherapies for locally advanced or metastatic disease.

Prior treatment with an EGFR TKI is allowed unless the participant had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI

Critères de non-inclusion :
  1. Previously received TAK-788.

  2. Received small-molecule anticancer therapy (including cytotoxic chemotherapy, and investigational agents, <=14 days prior to first dose of TAK-788 (except for reversible EGFR TKIs [that is, erlotinib or gefitinib], which are allowed in the dose escalation and expansion cohorts up to 7 days prior to the first dose of TAK-788).

  3. Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788.

  4. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.

    Note: This exclusion criteria does not apply to Expansion Cohort 7.

  5. Received radiotherapy <=14 days prior to the first dose of TAK-788. SRS and stereotactic body radiosurgery are allowed up to 7 days prior to the first dose.

  6. Received a strong CYP4503A inhibitor or strong CYP3A inducer within 2 weeks prior to first dose of TAK-788.

  7. Have undergone major surgery within 28 days prior to first dose of TAK-788. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.

  8. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring corticosteroids to control symptoms within 7 days prior to the first dose of TAK-788.

  9. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).

  10. Have significant, uncontrolled, or active cardiovascular disease.

  11. Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.

  12. Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes.

  13. Have an ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of history.

  14. Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.

  15. Female participants who are lactating and breastfeeding or have a positive urine or serum pregnancy test during the screening period.

    Note: Female participants who are lactating will be eligible if they discontinue breastfeeding.

  16. Have gastrointestinal illness or disorder that could affect oral absorption of TAK-788.

  17. Have any condition or illness that, in the opinion of the investigator, might compromise participant safety or interfere with the evaluation of the safety of the drug.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Hervé Lena - herve.lena@chu-rennes.fr ARCs/IRCs Pneumologie - ide-pneumo-arc@chu-rennes.fr nc / nc À venir 20/12/2018
Afficher les détails
Acronyme : "ARRAY-818-302  2015-005805-35 BEACON CRC
Spécialité : Digestif
Traitement : Récidive
Ouvert aux inclusions : Non

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Safety Lead-in, Triplet Arm
Encorafenib + binimetinib + cetuximab.

Experimental: Doublet Arm
Encorafenib + cetuximab.

Active Comparator: Control Arm
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.
Interventions:
Drug: Cetuximab
Drug: Irinotecan
Drug: Folinic Acid
Drug: 5-Fluorouracil

Informations

Cancer Colorectal Métastatique

BRAF V600E-mutant

2ème ligne et +

Phase 3

Promoteur: Array BioPharma
Acronymes: 2015-005805-35
BEACON CRC
Contact promoteur:
Array BioPharma
Mail promoteur: clinicaltrials@arraybiopharma.com

Tel promoteur:
303-381-6604

-
Source: Clinical trial.gov du 25/06/2018"

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

Critères d'inclusion :
  1. Age ≥ 18 years at time of informed consent

  2. Histologically- or cytologically-confirmed CRC that is metastatic

  3. Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory

  4. Progression of disease after 1 or 2 prior regimens in the metastatic setting

  5. Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1

  6. Adequate bone marrow, cardiac, kidney and liver function

  7. Able to take oral medications

  8. Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of childbearing potential

  9. Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-u

Critères de non-inclusion :
  1. Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab, panitumumab or other EGFR inhibitors

  2. Prior irinotecan hypersensitivity or toxicity that would suggest an inability to tolerate irinotecan 180 mg/m2 every 2 weeks

  3. Symptomatic brain metastasis or leptomeningeal disease

  4. History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)

  5. Known history of acute or chronic pancreatitis

  6. History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization

  7. Uncontrolled blood pressure despite medical treatment

  8. Impaired GI function or disease that may significantly alter the absorption of encorafenib or binimetinib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)

  9. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy

  10. History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli

  11. Concurrent neuromuscular disorder that is associated with the potential of elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)

  12. Residual CTCAE ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy

  13. Known history of HIV infection

  14. Active hepatitis B or hepatitis C infection

  15. Known history of Gilbert's syndrome

  16. Known contraindication to receive cetuximab or irinotecan at the planned doses

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - CHU Hépato-Digestif Dr Touchefeu Yann - DZIUKALA Catherine - / Non 01/02/2019
Brest - CHU de Brest - Site Morvan Dr J. P. Metges - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr NC / NC Non 01/02/2019
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