Back to resultsA Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
Primary Purpose
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
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INIPARIB + irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Estrogen Receptor Negative (ER-Negative) Breast Cancer focused on measuring Triple negative breast cancer, Brain metastasis, BSI-201, iniparib
Eligibility Criteria
Inclusion Criteria -
- Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
- ECOG Performance Status of 0-2.
- Life expectancy of >12 weeks.
- 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.
- No active serious infection or other comorbid illness which would impair ability to participate in the trial.
- Stable or decreasing dose of steroids for ≥ 7 days.
- Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy.
- Patients must have adequate organ function.
Exclusion Criteria -
- Pregnant or breast-feeding
- Prior allergic reaction to INIPARIB
- Prior allergic reaction to irinotecan.
- Evidence of hemorrhage or impending herniation on baseline brain imaging
- Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
- Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
- Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
- Contraindication to gadolinium-enhanced MRI imaging.
- Inability to comply with study and/or follow-up procedures.
Sites / Locations
- University of Alabama At Birmingham
- University of California At San Francisco
- Georgetown University
- University of Chicago
- Indiana University Simon Cancer Center
- Johns Hopkins University
- Dana Farber Cancer Institute
- University of Michigan
- University of North Carolina-CH Lineberger Comprehensive Cancer Center
- Duke University
- University of Pittsburgh Medical Center
- Vanderbilt University
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INIPARIB, irinotecan
Arm Description
Outcomes
Primary Outcome Measures
Efficacy
AS measured by intra or extra cranial time to progression (TTP)
Secondary Outcome Measures
Response Rate
as measured by RECIST
Full Information
NCT ID
NCT01173497
First Posted
July 28, 2010
Last Updated
February 17, 2016
Sponsor
Sanofi
Collaborators
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01173497
Brief Title
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
UNC Lineberger Comprehensive Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Triple negative breast cancer, Brain metastasis, BSI-201, iniparib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INIPARIB, irinotecan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
INIPARIB + irinotecan
Intervention Description
21 day cycle
Primary Outcome Measure Information:
Title
Efficacy
Description
AS measured by intra or extra cranial time to progression (TTP)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Response Rate
Description
as measured by RECIST
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria -
Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
ECOG Performance Status of 0-2.
Life expectancy of >12 weeks.
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.
No active serious infection or other comorbid illness which would impair ability to participate in the trial.
Stable or decreasing dose of steroids for ≥ 7 days.
Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy.
Patients must have adequate organ function.
Exclusion Criteria -
Pregnant or breast-feeding
Prior allergic reaction to INIPARIB
Prior allergic reaction to irinotecan.
Evidence of hemorrhage or impending herniation on baseline brain imaging
Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
Contraindication to gadolinium-enhanced MRI imaging.
Inability to comply with study and/or follow-up procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
University of California At San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
University of North Carolina-CH Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
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