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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01173497
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : March 17, 2016
UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Estrogen Receptor Negative (ER-Negative) Breast Cancer Progesterone Receptor Negative (PR-Negative) Breast Cancer Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer Brain Metastases Drug: INIPARIB + irinotecan Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the PARP Inhibitor, INIPARIB (BSI-201), in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
Study Start Date : July 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: INIPARIB, irinotecan Drug: INIPARIB + irinotecan
21 day cycle

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 12 months ]
    AS measured by intra or extra cranial time to progression (TTP)

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 12 months ]
    as measured by RECIST

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria -

  1. Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
  2. ECOG Performance Status of 0-2.
  3. Life expectancy of >12 weeks.
  4. No limit to prior therapies with last anti-cancer treatment ≥ 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to ≤Grade 1 or baseline.
  5. No active serious infection or other comorbid illness which would impair ability to participate in the trial.
  6. Stable or decreasing dose of steroids for ≥ 7 days.
  7. Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy.
  8. Patients must have adequate organ function.

Exclusion Criteria -

  1. Pregnant or breast-feeding
  2. Prior allergic reaction to INIPARIB
  3. Prior allergic reaction to irinotecan.
  4. Evidence of hemorrhage or impending herniation on baseline brain imaging
  5. Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
  6. Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
  7. Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
  8. Contraindication to gadolinium-enhanced MRI imaging.
  9. Inability to comply with study and/or follow-up procedures.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01173497

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United States, Alabama
University of Alabama At Birmingham
Birmingham, Alabama, United States
United States, California
University of California At San Francisco
San Francisco, California, United States
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, North Carolina
University of North Carolina-CH Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599-7295
Duke University
Durham, North Carolina, United States
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi Identifier: NCT01173497     History of Changes
Other Study ID Numbers: TCD11608
20100210 ( Other Identifier: BiPar )
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: February 2016

Keywords provided by Sanofi:
Triple negative breast cancer
Brain metastasis

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors