Phase 1 Safety Testing of SAR405838
This study is currently recruiting participants.
Verified May 2013 by Sanofi
Information provided by (Responsible Party):
First received: July 2, 2012
Last updated: May 16, 2013
Last verified: May 2013
- 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.
|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|
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) ] [ Designated as safety issue: Yes ]
- In MTD cohort, clinical benefit [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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:||February 2015|
|Estimated Primary Completion Date:||February 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 + 6 months from the first dose.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636479
|Contact: For site information, send an email with site number to||Contact-Us@Sanofi.com|
|Investigational Site Number 528001||Recruiting|
|Amsterdam, Netherlands, 1066 CX|
|Investigational Site Number 528003||Recruiting|
|Rotterdam, Netherlands, 3075 EA|
|Investigational Site Number 528002||Recruiting|
|Utrecht, Netherlands, 3584 CX|
Sponsors and Collaborators
|Study Director:||Clinical Sciences & Operations||Sanofi|