Phase 1 Safety Testing of SAR405838
|ClinicalTrials.gov Identifier: NCT01636479|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2012
Last Update Posted : August 14, 2017
- 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)|
|Estimated Enrollment :||82 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|
|Actual Study Start Date :||July 13, 2012|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
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 ]
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|