Étude de phase 1 portant sur le BLU-667, un inhibiteur RET hautement sélectif, chez des patients atteints de cancer de la thyroïde, de cancer bronchique non à petites cellules (CBNPC) et d’autres tumeurs solides avancées avec altération de RET
Type d'étude | Promoteur | Etat actuel de l'étude |
Interventionnelle |
Blueprint Medicines Corporation | En cours de recrutement |
Étude de phase 1 portant sur le BLU-667, un inhibiteur RET hautement sélectif, chez des patients atteints de |
|
Code de l’étude |
NCT03037385 |
Promoteur |
Blueprint Medicines Corporation |
Tumeur éligible |
RET-altered Non Small Cell Lung Cancer, RET altered Medullary Thyroid Cancer, RET-altered Papillary Thyroid Cancer, RET-altered Colon Cancer, RET-altered Solid Tumors |
Type d’étude |
Interventionnelle |
Phase |
1 |
Nombre de patients à inclure |
360 participants |
Contact |
|
Centres |
Internationale, France: Institut Gustave Roussy, Institut Bergonié (bordeaux), CHRU Lille, Centre Leon Berard (Lyon), Institut Claudius Regaud (Toulouse) |
Objectifs |
Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of BLU-667 [ Time Frame: Cycle 1 (28 days) of treatment for MTD and at the end of every cycle (28 days) for RP2D for approximately 12 months or earlier if patient terminates from the study ] Number of patients with adverse events and serious adverse events [ Time Frame: Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study, and 30 days after the last dose ] Overall response rate [ Time Frame: Approximately every 8 weeks during treatment, 14 days after the last dose, and every 3 months after the last dose (up to 2 years) in patients without progressive disease |
Critères d’inclusion |
• Diagnosis during dose escalation (Part 1) - Pathologically documented, definitively diagnosed non-resectable advanced solid tumor. |
Critères d’exclusion |
• 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. |