- To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent
and in combination with chemotherapeutic regimens in patients with advanced solid tumors
that are refractory to standard therapy.
- To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid
Tumors [RECIST]) Version 1.1 in patients with measurable disease.
- To characterize iniparib (and its metabolites, if possible) pharmacokinetics.
Based on data generated by 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.