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A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01033292
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

December 14, 2009
December 16, 2009
March 17, 2016
December 2009
December 2012   (Final data collection date for primary outcome measure)
To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: Until progressive disease or death ]
Same as current
Complete list of historical versions of study NCT01033292 on ClinicalTrials.gov Archive Site
  • To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: 30 days after last BSI-201 exposure ]
  • To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: until progressive disease or death ]
Same as current
Not Provided
Not Provided
 
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer

The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-resistant recurrent ovarian cancer patients receiving gemcitabine and carboplatin.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
Drug: BSI-201
IV infusion, 5.6 mg/kg
Other Name: PARP inhibitor
Experimental: BSI-201
BSI-201 in combination with gemcitabine and carboplatin.
Intervention: Drug: BSI-201
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
48
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years of age
  • Histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma
  • Completion of only one previous course of chemotherapy which contained a platinum therapy, with resistance to that regimen. "Platinum-resistance" is defined by a relapse within 2 to 6 months after termination of platinum-based chemotherapy
  • Measurable disease, defined by at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded), and is ≥ 20 mm when measured by conventional techniques (palpation, plain x-ray, computed tomography [CT], or magnetic resonance imaging [MRI]) or ≥ 10 mm when measured by spiral CT
  • Adequate organ function defined as: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, creatinine clearance > 50mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN; or < 5 x ULN in case of liver metastases); total bilirubin < 1.5 mg/dL
  • For women of child bearing potential, documented negative pregnancy test within two weeks of study entry and agreement to acceptable birth control during the duration of the study therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Signed, institutional review board (IRB) approved written informed consent

Exclusion Criteria:

  • Concurrent invasive malignancy, not including:

    1. Non-melanomatous skin cancer
    2. In situ malignancies
    3. Concurrent superficial endometrial carcinoma, if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium)
    4. Low risk breast cancer (localized, non-inflammatory) treated with curative intent
  • Lesions identifiable only by positron emission tomography (PET)
  • Prior treatment with poly (ADP-ribose) polymerase (PARP) inhibitors, including BSI-201
  • Major medical conditions that might affect study participation (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection)
  • Other significant co-morbid condition which the investigator feels might compromise effective and safe participation in the study, including a history of congestive cardiac failure or an electrocardiogram (ECG) suggesting significant conduction defect or myocardial ischemia
  • Enrollment in another investigational device or drug study, or current treatment with other investigational agents
  • Concurrent radiation therapy to treat primary disease throughout the course of the study
  • Inability to comply with the requirements of the study
  • Pregnancy or lactation
  • Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01033292
TCD11504
20090208 ( Other Identifier: BiPar )
No
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2016

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