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

July 28, 2010
September 14, 2013
July 2010
October 2012   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
AS measured by intra or extra cranial time to progression (TTP)
Same as current
Complete list of historical versions of study NCT01173497 on ClinicalTrials.gov Archive Site
Response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
as measured by RECIST
Same as current
Not Provided
Not Provided
 
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis
A Phase II Study of the PARP Inhibitor, INIPARIB (BSI-201), in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
21 day cycle
Experimental: INIPARIB, irinotecan
Intervention: Drug: INIPARIB + irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
September 2013
October 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01173497
TCD11608, 20100210
Not Provided
Sanofi
Sanofi
UNC Lineberger Comprehensive Cancer Center
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP