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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 77 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01636479
The ClinicalTrials.gov registry entry for NCT01636479 describes a study currently listed as completed, 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 Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SAR405838 is the first listed.
NCT01636479 reports 0 study locations.
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.
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