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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01033292
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: BSI-201 Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Study Start Date : December 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: BSI-201
BSI-201 in combination with gemcitabine and carboplatin.
Drug: BSI-201
IV infusion, 5.6 mg/kg
Other Name: PARP inhibitor

Primary Outcome Measures :
  1. To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: Until progressive disease or death ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: until progressive disease or death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01033292

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United States, Massachusetts
Massachusetts Ceneral Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi Identifier: NCT01033292     History of Changes
Other Study ID Numbers: TCD11504
20090208 ( Other Identifier: BiPar )
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: February 2016

Keywords provided by Sanofi:
platinum-resistant recurrent ovarian cancer

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Poly(ADP-ribose) Polymerase Inhibitors