Phase 1 Safety Testing of SAR405838

Phase 1

Completed

• Conditions: Neoplasm Malignant
• Interventions: Drug: SAR405838

• Registration Number: NCT01636479
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Study Start: 2012-07-13
• Primary Completion: 2018-03-05
• Study Completion: 2018-03-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR405838	SAR405838	SAR405838 in escalating doses

Primary Outcome Measures

Name	Time	Method
In MTD cohort, clinical benefit	Until disease progression
SAR405838 Maximum tolerated dose (MTD)	Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule

Secondary Outcome Measures

Name	Time	Method
PK parameters (Cmax, Tmax, AUC)	Baseline to end of study
Biomarkers	Baseline to end of study
Clinical response	Baseline to end of study
Adverse events (eg, number of patients experiencing AEs)	Baseline to end of study
Drug administration compliance	Baseline to end of study

Trial Locations

Locations (7)

Investigational Site Number 840101; 🇺🇸 Boston, Massachusetts, United States

Investigational Site Number 840001; 🇺🇸 Boston, Massachusetts, United States

Investigational Site Number 840002; 🇺🇸 New York, New York, United States

Investigational Site Number 250001; 🇫🇷 Villejuif, France

Investigational Site Number 528003; 🇳🇱 Rotterdam, Netherlands

Investigational Site Number 528001; 🇳🇱 Amsterdam, Netherlands

Investigational Site Number 528002; 🇳🇱 Utrecht, Netherlands