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Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT 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, andrew_wolanski@dfci.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria - Meets protocol-specified criteria for qualification and contraception - Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications - Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Exclusion Criteria: - Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters - Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) 3. the analysis of results
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