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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BSI-201
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian, cancer, sensitive, PARP, recurrent, platinum-sensitive recurrent ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts Ceneral Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BSI-201

Arm Description

BSI-201 in combination with gemcitabine and carboplatin.

Outcomes

Primary Outcome Measures

To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201

Secondary Outcome Measures

To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201
To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201

Full Information

First Posted
December 14, 2009
Last Updated
February 17, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01033123
Brief Title
A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian, cancer, sensitive, PARP, recurrent, platinum-sensitive recurrent ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BSI-201
Arm Type
Experimental
Arm Description
BSI-201 in combination with gemcitabine and carboplatin.
Intervention Type
Drug
Intervention Name(s)
BSI-201
Other Intervention Name(s)
PARP inhibitor
Intervention Description
IV infusion, 5.6 mg/kg
Primary Outcome Measure Information:
Title
To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201
Time Frame
Until progressive disease or death
Secondary Outcome Measure Information:
Title
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
Title
To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201
Time Frame
until progressive disease or death

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Non-melanomatous skin cancer In situ malignancies Concurrent superficial endometrial carcinoma, if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts Ceneral Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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