Safety and Pharmacokinetics of SAR240550 (BSI-201) Twice Weekly in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advance Solid Tumors
• Interventions: Drug: Iniparib (SAR240550 - BSI-201); Drug: Gemcitabine; Drug: Carboplatin

• Registration Number: NCT01213381
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens

Secondary Objectives:

* To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination with chemotherapy regimen (gemcitabine and carboplatin

* To assess safety profiles: significant laboratory changes and adverse events (AEs)

* To make a preliminary assessment of antitumor effect in study subjects per Response Evaluation Criteria in Solid Tumors (RECIST) with measurable disease

* To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and 4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics

* To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Detailed Description

The duration of the study for each patient will include an up to 4-week screening phase, 21-day study cycle(s), followed by a 30 day follow-up.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-23
• Last Update Posted: 2013-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR240550	Iniparib (SAR240550 - BSI-201)	* single cohort: SAR240550 * combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin
SAR240550	Carboplatin	* single cohort: SAR240550 * combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin
SAR240550	Gemcitabine	* single cohort: SAR240550 * combination cohort: SAR240550 in combination with Gemcitabine and Carboplatin

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity in cycle 1	3 Weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy assessment as tumor response defined by Response Evaluation Criteria in Solid Tumors (RECIST)	30 days after the last injection
Safety based on clinical and laboratory tests and Adverse Events (AEs)	30 days after the last injection
Pharmacokinetics of SAR240550	Cycle 1 and Cycle 2
Pharmacodynamics of SAR240550	Cycle1, Cycle 2 and 30 days after the last injection
Pharmacogenomic analysis of glutathione S-transferase (GST) genotypes	Cycle 1

Trial Locations

Locations (2)

Sanofi-Aventis Investigational Site Number 392001; 🇯🇵 Kobe-Shi, Japan

Sanofi-Aventis Investigational Site Number 392002; 🇯🇵 Matsuyama-Shi, Japan