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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033123
• Other study ID #: TCD11503
• Secondary ID: 20090207
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2009
• Last updated: February 17, 2016
• Start date: December 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• BSI-201
IV infusion, 5.6 mg/kg

Locations

Country	Name	City	State
United States	Massachusetts Ceneral Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the objective response rate (ORR) of gemcitabine/carboplatin in combination with BSI-201		Until progressive disease or death	No
Secondary	To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201		30 days after last BSI-201 exposure	Yes
Secondary	To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201		until progressive disease or death	No