An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer
Status:
No longer available
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The following trial is designed to offer pre-approval drug access to iniparib in combination
with gemcitabine and carboplatin in order to provide potential clinical benefit to patients
with ER-, PR-, and HER2-negative metastatic breast cancer. This follows an ongoing Phase 3,
multi-center, open-label, randomized study of gemcitabine/carboplatin, with or without
iniparib, in patients with ER-, PR-, and HER2-negative metastatic breast cancer (protocol
20090301).
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.