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An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer

NCT01130259 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2013-09-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01130259 on ClinicalTrials.gov