Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00677079

Purpose

This is a single institution, single arm study of BSI-201 in patients with advanced BRCA-1 or BRCA-2 associated epithelial ovarian, fallopian tube, or primary peritoneal cancer. BSI-201 is a small molecule inhibitor of poly ADP-ribose polymerase-1 (PARP-1). The goal of this study is to determine if BSI-201 is efficacious in this patient population. Eligible patients will have received initial treatment with platinum/taxane combination therapy and have no curative options as determined by their physician. There will be no limit on the number of prior therapies. A maximum of 35 patients will be treated in this study using a Simon two-stage optimal design.

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
Primary Peritoneal Cancer Advanced Epithelial Ovarian Cancer	Drug: Iniparib (SAR240550 - BSI-201)	Phase II

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: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Response rate (CR + PR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

clinical benefit rate (CR + PR + SD) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	May 2008
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Iniparib (SAR240550 - BSI-201) iv, 2 x weekly

Eligibility

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

Criteria

Inclusion Criteria:

Female, age 18 or older.
Histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage III or IV).
Patients must have received at least one regimen of platinum/taxane therapy.
Confirmed BRCA1 or BRCA2 status.
One or more measurable lesions, at least 10mm in longest diameter by spiral CT scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or MRI).
Karnofsky performance status ≥70%.
Estimated life expectancy of at least 16 weeks.

Exclusion Criteria:

Normal clinical laboratory values:
Any anti-cancer therapy within 21 days prior to day 1.
Any other malignancy within 3 years of day 1, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, or basal or squamous cell skin cancer.
Active viral infection including HIV/AIDS, Hepatitis B or Hepatitis C infection.
Active central nervous system or brain metastases.
History of seizures or current treatment with anti-epileptic medication.
Persistent grade 2 or greater toxicities from prior therapy, excluding alopecia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677079

Locations

United States, New York

New York, New York, United States, 10021

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00677079 History of Changes
Other Study ID Numbers:	ARD11489, 20080105
Study First Received:	May 9, 2008
Last Updated:	November 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

BRCA-1 or BRCA-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
BRCA-1
BRCA-2

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 09, 2012