An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01130259|
Expanded Access Status : No longer available
First Posted : May 25, 2010
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Drug: iniparib|
|Study Type :||Expanded Access|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||An Open-Label, Expanded Access Protocol of Iniparib in Combination With Gemcitabine/Carboplatin in Patients With ER-, PR-, and HER2-Negative Metastatic Breast Cancer|
- Drug: iniparib
5.6 mg/kg as a 60 (±10) minutes IV infusion. Administered on Days 1, 4, 8, and 11 of each 21 day cycle.Other Name: BSI-201
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130259
|Study Director:||Clinical Sciences & Operations||Sanofi|