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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: Clinical Trial Phase 1 study, sponsored by Debiopharm International.
NCT01948297 is a Phase 1 study that was terminated before completion, run by Debiopharm International. The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT01948297 stopped before completion
NCT01948297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 1 intervention - of which Debio1347 (CH5183284) is the first listed.
NCT01948297 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01948297's enrollment target sits among peer trials
77 703rd of 2000 higher than 1,296 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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