NCT01033123

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2 ovarian-cancer

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

Study Start

First participant enrolled

December 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

December 14, 2009

Last Update Submit

February 17, 2016

Conditions

Ovarian Cancer

Keywords

ovariancancersensitivePARPrecurrentplatinum-sensitive recurrent ovarian cancer

Outcome Measures

Primary Outcomes (1)

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

    Until progressive disease or death

Secondary Outcomes (2)

  • To determine the nature and degree of toxicity of gemcitabine/carboplatin in combination with BSI-201

    30 days after last BSI-201 exposure

  • To evaluate progression-free survival (PFS) of gemcitabine/carboplatin in combination with BSI-201

    until progressive disease or death

Study Arms (1)

BSI-201

EXPERIMENTAL

BSI-201 in combination with gemcitabine and carboplatin.

Drug: BSI-201

Interventions

BSI-201DRUG

IV infusion, 5.6 mg/kg

Also known as: PARP inhibitor
BSI-201

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Ceneral Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Penson RT, Ambrosio AJ, Whalen CA, Krasner CN, Konstantinopoulos PA, Bradley C, Matulonis UA, Birrer MJ. Phase II Trials of Iniparib (BSI-201) in Combination with Gemcitabine and Carboplatin in Patients with Recurrent Ovarian Cancer. Oncologist. 2023 Mar 17;28(3):252-257. doi: 10.1093/oncolo/oyac275.

    PMID: 36718018DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasmsHypersensitivityRecurrence

Interventions

iniparibPoly(ADP-ribose) Polymerase Inhibitors

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic AgentsTherapeutic Uses

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

December 14, 2009

First Posted

December 16, 2009

Study Start

December 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 17, 2016

Record last verified: 2016-02

Locations

US(1)