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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 1. Signed written informed consent approved before undertaking any study-specific procedures. 2. Patients with advanced solid malignancies, whose tumours have an alteration of the FGFR 1, 2 or 3 genes, confirmed by local site genetic tests on a biopsy. 3. Age ≥ 18 years. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2. 5. Histologically or cytologically confirmed advanced solid tumour that has recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy exists. 6. Patients have measurable or non-measurable disease. 7. Adequate organ function in bone marrow, cardiovascular, hepatic and renal systems. Exclusion Criteria: 1. History of hypersensitivity to any of the excipients in the Debio 1347 (CH5183284) formulation. 2. History of another malignancy, unless patient has been disease-free for 5 years. 3. Patients with brain tumours and/or brain metastases unless brain metastases are asymptomatic and they are not currently receiving corticosteroids and/or anticonvulsants. 4. History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis. 5. History and or current evidence of ectopic mineralisation/calcification including but not limited to the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification. 6. Concomitant use of a systemic steroid or any other drug that affect calcium and phosphorus metabolism. 7. Corneal disease, such as bullous or band keratopathy, corneal desquamation, keratitis, corneal ulcer, or keratoconjunctivitis. Other protocol-defined inclusion/exclusion criteria may apply.
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