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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01033123
First received: December 14, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to evaluate the effect of BSI-201 on the objective response rate in platinum-sensitive 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 Intervention Phase
Ovarian Cancer
Drug: BSI-201
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 2, Multi-Center, Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: Until progressive disease or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201 [ Time Frame: until progressive disease or death ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BSI-201
BSI-201 in combination with gemcitabine and carboplatin.
Drug: BSI-201
IV infusion, 5.6 mg/kg
Other Name: PARP inhibitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 sensitivity to that regimen. "Platinum-sensitivity" is defined by a relapse greater than 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033123

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01033123     History of Changes
Other Study ID Numbers: TCD11503, 20090207
Study First Received: December 14, 2009
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Sanofi:
ovarian
cancer
sensitive
PARP
recurrent
platinum-sensitive recurrent ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014