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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by (Responsible Party): | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT01130259 |
Purpose
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 | Intervention |
|---|---|
|
Breast Cancer |
Drug: iniparib |
| Study Type: | Expanded Access What is Expanded Access? |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Enrollment is limited and will be determined by a validated Random-Selection Process administered by NORD (National Organization of Rare Disorders).
Contacts and Locations
More Information
| Responsible Party: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT01130259 History of Changes |
| Other Study ID Numbers: | EFC11614, 2010EAP |
| Study First Received: | May 24, 2010 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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mTNBC triple negative breast cancer metastatic triple negative breast cancer metastatic breast cancer that is ER-, PR-, and HER2-negative |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |