Trials / Completed
CompletedNCT01636479
Phase 1 Safety Testing of SAR405838
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAR405838 | Pharmaceutical form: Capsule Route of administration: Oral |
Timeline
- Start date
- 2012-07-13
- Primary completion
- 2018-03-05
- Completion
- 2018-03-05
- First posted
- 2012-07-10
- Last updated
- 2018-05-17
Locations
7 sites across 3 countries: United States, France, Netherlands
Source: ClinicalTrials.gov record NCT01636479. Inclusion in this directory is not an endorsement.