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NCT01636479 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Safety Testing of SAR405838
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT01636479: Completed Phase 1 study, sponsored by Sanofi.
NCT01636479 is a Phase 1 study that has completed, run by Sanofi. 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
NCT01636479, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study Summary
Primary Objectives: * To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). * To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: * Pharmacokinetic (PK) profile of SAR405838. * Biomarkers in association with SAR405838. * Anti-tumor activity in response to SAR405838. * Food effect on SAR405838 PK. * Compliance with SAR405838 treatment. * Cytochrome P450 3A4/5 (CYP3A4/5) activity.
Interventions
- DRUG SAR405838
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2012-07-13 |
| Est. Completion | 2018-03-05 |
| Phase | Phase 1 |
What the finished NCT01636479 record still lists
NCT01636479 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 SAR405838 is the first listed.
NCT01636479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01636479 about?
NCT01636479 is a clinical study titled "Phase 1 Safety Testing of SAR405838". Primary Objectives: * To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). * To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: * Pharmac...
What is the current status of trial NCT01636479?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2012-07-13. Estimated completion is 2018-03-05.
What interventions are being tested in trial NCT01636479?
The interventions under investigation include: SAR405838 (DRUG).
Who is sponsoring clinical trial NCT01636479?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01636479'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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