Advance Solid Tumors Clinical Trial
Official title:
A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.
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.
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. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment