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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT01173497
Phase
PHASE2
Status
Completed

Conditions

  • Brain Metastases
  • Estrogen Receptor Negative (ER-Negative) Breast Cancer
  • Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer
  • Progesterone Receptor Negative (PR-Negative) Breast Cancer

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2010
Status verified
Feb 2016
Primary completion
Oct 31, 2012
Completion
Jul 31, 2013

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: INIPARIB, irinotecan

Primary Outcome Measure

Efficacy [ Time Frame: 12 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Alabama At BirminghamBirminghamAlabama--
University of California At San FranciscoSan FranciscoCalifornia--
Georgetown UniversityWashington D.C.District of Columbia--
University of ChicagoChicagoIllinois--
Indiana University Simon Cancer CenterIndianapolisIndiana--
Johns Hopkins UniversityBaltimoreMaryland--
Dana Farber Cancer InstituteBostonMassachusetts--
University of MichiganAnn ArborMichigan--
University of North Carolina-CH Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-7295-
Duke UniversityDurhamNorth Carolina--
University of Pittsburgh Medical CenterPittsburghPennsylvania--
Vanderbilt UniversityNashvilleTennessee--
MD Anderson Cancer CenterHoustonTexas--

Find similar trials in Birmingham, AL

By research site
University of Alabama At Birmingham· Birmingham, ALUniversity of California At San Francisco· San Francisco, CAGeorgetown University· Washington D.C., DCUniversity of Chicago· Chicago, ILIndiana University Simon Cancer Center· Indianapolis, INJohns Hopkins University· Baltimore, MD

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