Phase 1 Safety Testing of SAR405838
- 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.
- 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer|
- SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule ] [ Designated as safety issue: No ]
- In MTD cohort, clinical benefit [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
- Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
- PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
- Biomarkers [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
- Clinical response [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
- Drug administration compliance [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
SAR405838 in escalating doses
Pharmaceutical form: Capsule Route of administration: Oral
Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636479
|United States, Massachusetts|
|Investigational Site Number 840001|
|Boston, Massachusetts, United States, 02115|
|Investigational Site Number 840101|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|Investigational Site Number 840002|
|New York, New York, United States, 10021|
|Investigational Site Number 250001|
|Villejuif, France, 94805|
|Investigational Site Number 528001|
|Amsterdam, Netherlands, 1066 CX|
|Investigational Site Number 528003|
|Rotterdam, Netherlands, 3075 EA|
|Investigational Site Number 528002|
|Utrecht, Netherlands, 3584 CX|
|Study Director:||Clinical Sciences & Operations||Sanofi|