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

Primary Peritoneal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677079
• Other study ID #: ARD11489
• Secondary ID: 20080105
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2008
• Last updated: September 23, 2013
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: September 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer.

Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.

Description:

Participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per RECIST criteria) and wished to remain on study.

Participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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);

• At least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies);

• Confirmed BRCA1 or BRCA2 status;

• One or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (CT) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or magnetic resonance imaging (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 study start;

• Any other malignancy within 3 years of study start, 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.

Study Design

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

Related Conditions & MeSH terms

• Advanced Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cancer

Intervention

Drug:
• Iniparib
Body weight adjusted dose 1 hour intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best overall response	Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.	until treatment discontinuation (assessment at the at the end of each 8-week cycle)	No
Primary	Objective response rate	Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.	until treatment discontinuation (assessment at the at the end of each 8-week cycle)	No
Secondary	Clinical benefit rate	Clinical benefit rate was defined as the percentage of participants with complete response, partial response or stable disease according to RECIST criteria.	until treatment discontinuation (assessment at the at the end of each 8-week cycle)	No
Secondary	Progression-Free Survival	Progression-free survival was defined as the time interval from study entry until disease progression or death due to any cause, whichever came first.; In the absence disease progression or death, progression-free survival was censored at the last date the participant was known to be alive.	until death or study end	No
Secondary	Overall Survival	Overall Survival was defined as the time interval from study entry until death due to any cause.; In the absence of confirmation of death, progression-free survival was censored at the last date the participant was known to be alive.	until death or study end	No
Secondary	Cancer antigen 125 response (participants with elevated CA125)	Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels.	until treatment discontinuation (assessment at the at the end of each 8-week cycle)	No