A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

Phase 2

Completed

• Conditions: Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer; Estrogen Receptor Negative (ER-Negative) Breast Cancer; Progesterone Receptor Negative (PR-Negative) Breast Cancer; Brain Metastases
• Interventions: Drug: INIPARIB + irinotecan

• Registration Number: NCT01173497
• Lead Sponsor: Sanofi

Brief Summary

The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-08-02
• Primary Completion: 2012-10
• Study Completion: 2013-07
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-17
• Disposition First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Disposition First Posted: 2016-03-17
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INIPARIB, irinotecan	INIPARIB + irinotecan	-

Primary Outcome Measures

Name	Time	Method
Efficacy	12 months	AS measured by intra or extra cranial time to progression (TTP)

Secondary Outcome Measures

Name	Time	Method
Response Rate	12 months	as measured by RECIST

Trial Locations

Locations (13)

University of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of California At San Francisco; 🇺🇸 San Francisco, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of North Carolina-CH Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States