Phase 1 Safety Testing of SAR405838
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01636479|
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : May 17, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Malignant||Drug: SAR405838||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients With Advanced Cancer|
|Study Start Date :||July 13, 2012|
|Actual Primary Completion Date :||March 5, 2018|
|Actual Study Completion Date :||March 5, 2018|
SAR405838 in escalating doses
Pharmaceutical form: Capsule Route of administration: Oral
- SAR405838 Maximum tolerated dose (MTD) [ Time Frame: Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule ]
- In MTD cohort, clinical benefit [ Time Frame: Until disease progression ]
- Adverse events (eg, number of patients experiencing AEs) [ Time Frame: Baseline to end of study ]
- PK parameters (Cmax, Tmax, AUC) [ Time Frame: Baseline to end of study ]
- Biomarkers [ Time Frame: Baseline to end of study ]
- Clinical response [ Time Frame: Baseline to end of study ]
- Drug administration compliance [ Time Frame: Baseline to end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636479
|United States, Massachusetts|
|Investigational Site Number 840101|
|Boston, Massachusetts, United States, 02114|
|Investigational Site Number 840001|
|Boston, Massachusetts, United States, 02115|
|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|