Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
This study is currently recruiting participants.
Verified January 2014 by Debiopharm International SA
Information provided by (Responsible Party):
Debiopharm International SA
First received: August 26, 2013
Last updated: January 22, 2014
Last verified: January 2014
This study is primarily designed to assess the safety and the tolerability of Debio 1347(CH5183284) at increasing doses in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes.
Drug: Debio 1347 (CH5183284)
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 Genes
Primary Outcome Measures:
- Incidence rate of dose limiting toxicities (DLTs) of Debio 1347 [ Time Frame: Approximately 18 months ] [ Designated as safety issue: Yes ]
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisions.
Secondary Outcome Measures:
- Safety and tolerability of Debio 1347 combination at the recommended dose (RDE) for expansion [ Time Frame: Every 28 days from baseline visit to 28 days after study drug discontinuation ] [ Designated as safety issue: Yes ]
This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions and reductions
- Markers of FGFR inhibition in plasma and tumor [ Time Frame: Baseline and day 8 ] [ Designated as safety issue: No ]
- Time vs. concentration profile of Debio 1347 [ Time Frame: Every 28 days for up to the end of the study ] [ Designated as safety issue: Yes ]
Plasma concentration versus time profiles. Plasma PK parameters will be used to characterize the PK profiles of Debio 1347
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
Experimental: Debio 1347 (CH5183284)
Eligible patients will receive Debio 1347(CH5183284)
Drug: Debio 1347 (CH5183284)
Debio 1347 (CH5183284) will be administered orally once daily on a continuous basis 28 day cycles until progression of disease or unacceptable toxicity.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Signed written informed consent approved before undertaking any study-specific procedures.
- 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.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
- 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.
- Patients have measurable or non-measurable disease.
- Adequate organ function in bone marrow, cardiovascular, hepatic and renal systems.
- History of hypersensitivity to any of the excipients in the Debio 1347 (CH5183284) formulation.
- History of another malignancy, unless patient has been disease-free for 5 years.
- Patients with brain tumours and/or brain metastases unless brain metastases are asymptomatic and they are not currently receiving corticosteroids and/or anticonvulsants.
- History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis.
- 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.
- Concomitant use of a systemic steroid or any other drug that affect calcium and phosphorus metabolism.
- Corneal disease, such as bullous or band keratopathy, corneal desquamation, keratitis, corneal ulcer, or keratoconjunctivitis.
Other protocol-defined inclusion/exclusion criteria may apply.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01948297
|Contact: Claudio Zanna, MD
|Contact: Christian Aeschlimann, MS
|Dana-Farber Cancer Institute
|Boston, Massachusetts, United States, 02114 |
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02215 |
|Memorial Sloan-Kettering Hospital
|New-York, New York, United States, 10065 |
|Contact: Martin Voss, MD 646-422-4631 |
|Vall d'Hebron University Hospital
|Barcelona, Spain |
|Contact: Josep Tabernero, MD +34-93-489-43-01 |
Debiopharm International SA
||José Baselga, MD, PhD
||Memorial Sloan-Kettering Hospital
No publications provided
||Debiopharm International SA
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 26, 2013
||January 22, 2014
||United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Molecular Mechanisms of Pharmacological Action