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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01173497
First received: July 28, 2010
Last updated: September 14, 2013
Last verified: September 2013
  Purpose

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 Intervention 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

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    AS measured by intra or extra cranial time to progression (TTP)


Secondary Outcome Measures:
  • Response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    as measured by RECIST


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: September 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INIPARIB, irinotecan Drug: INIPARIB + irinotecan
21 day cycle

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173497

Locations
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
Sanofi
UNC Lineberger Comprehensive Cancer Center
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01173497     History of Changes
Other Study ID Numbers: TCD11608, 20100210
Study First Received: July 28, 2010
Last Updated: September 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Triple negative breast cancer
Brain metastasis
BSI-201
iniparib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014