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:
Sanofi
Collaborator:
UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01173497
First received: July 28, 2010
Last updated: August 2, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | January 2013 |
| Estimated 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 -
- 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.
Contacts and Locations
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: | August 2, 2012 |
| 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 May 19, 2013