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Status: RecruitingPhase: Phase 1Diagnosis: Solid Tumor/Phase INCT ID: NCT01948297
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-251
This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment does not exist or is not indicated. The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally administered daily to these patients, in order to determine the recommended dose. The main objective of Part B is to evaluate the safety profile at the recommended dose, in a larger cohort of these patients.
Conducting Institutions: Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital
Overall PI: Rebecca Heist, MD,
Massachusetts General Hospital
Site-responsible Investigators: Leena Gandhi, MD, PhD,
Dana-Farber Cancer Institute
Contacts: Dana-Farber Cancer Institute:
Andrew Wolanski, 617-632-6623,
email@example.comMassachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100