NCT00677079

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

May 9, 2008

Last Update Submit

September 23, 2013

Conditions

Primary Peritoneal CancerAdvanced Epithelial Ovarian Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (4)

  • Clinical benefit rate

    until treatment discontinuation (assessment at the at the end of each 8-week cycle)

  • Progression-Free Survival

    until death or study end

  • Overall Survival

    until death or study end

  • Cancer antigen 125 response (participants with elevated CA125)

    until treatment discontinuation (assessment at the at the end of each 8-week cycle)

Study Arms (1)

Iniparib

EXPERIMENTAL

Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles

Drug: Iniparib

Interventions

IniparibDRUG

Body weight adjusted dose 1 hour intravenous infusion

Also known as: BSI-201, SAR240550
Iniparib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

New York, New York, 10021, United States

Location

Related Publications (1)

  • Bell-McGuinn KM, Konner JA, Tew WP, Hensley ML, Iasonos A, Charpentier E, Mironov S, Sabbatini P, Aghajanian C. A Phase 2, Single Arm Study of Iniparib in Patients With BRCA1 or BRCA2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Int J Gynecol Cancer. 2016 Feb;26(2):255-60. doi: 10.1097/IGC.0000000000000591.

    PMID: 26745694DERIVED

MeSH Terms

Conditions

Fanconi Anemia, Complementation Group D1

Interventions

iniparib

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 13, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

US(1)