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NCT01948297 · ClinicalTrials.gov registry record · Phase 1
Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
A Phase 1 study, sponsored by Debiopharm International.
- Terminated
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT01948297 is a Phase 1 study that was terminated before completion, run by Debiopharm International. The registered enrollment target is 77 participants.
The verdict
NCT01948297, a Phase 1 study, was terminated before completion, sponsored by Debiopharm International.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Debio1347 (CH5183284)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2013-08 |
| Est. Completion | 2020-06-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01948297
The ClinicalTrials.gov registry entry for NCT01948297 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Debio1347 (CH5183284) is the first listed.
NCT01948297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01948297 about?
NCT01948297 is a clinical study titled "Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations". 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 ind...
What is the current status of trial NCT01948297?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2013-08. Estimated completion is 2020-06-26.
What interventions are being tested in trial NCT01948297?
The interventions under investigation include: Debio1347 (CH5183284) (DRUG).
Who is sponsoring clinical trial NCT01948297?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
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