NCT01213381

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

A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advance Solid Tumors

Interventions

Type	Name	Description
DRUG	Iniparib (SAR240550 - BSI-201)	Pharmaceutical form:sterile aqueous solution Route of administration: intravenous
DRUG	Gemcitabine	Pharmaceutical form:sterile aqueous solution Route of administration: intravenous
DRUG	Carboplatin	Pharmaceutical form:sterile aqueous solution Route of administration: intravenous

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-10-04
• Last updated: 2013-05-24

Locations

2 sites across 1 country: Japan