A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
NCT ID: NCT00938652
Last Updated: 2013-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
519 participants
INTERVENTIONAL
2009-07-31
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm G/C
gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s)
gemcitabine/carboplatin
Gemcitabine 1000 mg/m2 intravenous infusion (30 ± 10 minutes)
Carboplatin AUC 2 intravenous infusion (30 ± 10 minutes or 60 ± 10 minutes)
Arm G/C/I
gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s)
gemcitabine/carboplatin
Gemcitabine 1000 mg/m2 intravenous infusion (30 ± 10 minutes)
Carboplatin AUC 2 intravenous infusion (30 ± 10 minutes or 60 ± 10 minutes)
Iniparib
Body weight adjusted dose
intravenous infusion (60 ± 10 minutes)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gemcitabine/carboplatin
Gemcitabine 1000 mg/m2 intravenous infusion (30 ± 10 minutes)
Carboplatin AUC 2 intravenous infusion (30 ± 10 minutes or 60 ± 10 minutes)
Iniparib
Body weight adjusted dose
intravenous infusion (60 ± 10 minutes)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Triple-negative tumors were defined by the following criteria:
* HER2-non-overexpressing: FISH-negative (defined by ratio \<2.2) or, immunohistochemical (IHC) 0, IHC 1+ or, IHC 2+ or IHC 3+ and FISH-negative.
* ER- and PR-negative: \<10% tumor staining by immunohistochemistry (IHC).
* Never having received chemotherapy for metastatic disease or, having received 1 or 2 prior chemotherapy regimens in the metastatic setting (Prior adjuvant/neoadjuvant therapy was allowed);
* Metastatic breast cancer (Stage IV) with measurable disease by RECIST 1.1 criteria;
* Female, ≥18 years of age;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Organ and marrow function as follows: absolute neutrophil count (ANC) ≥1500/mm3, platelets ≥100,000/dL, hemoglobin ≥9 g/dL, bilirubin ≤1.5 mg/dL, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement;
* Radiation therapy completed at least 14 days before study dosing on day 1; radiated lesions may not have served as measurable disease;
* Central nervous system metastases allowed if subject did not require steroids, whole brain radiation therapy (XRT), gamma/cyber knife, and brain metastases were clinically stable without symptomatic progression;
* 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;
* Tissue block (primary or metastatic) or readily available fresh frozen tumor tissue for PARP expression and other pharmacogenomic studies recommended (although its absence will not exclude subjects from participating);
* No other diagnosis of malignancy (with exception of non melanoma skin cancer or a malignancy diagnosed ≥5 years ago);
* Obtained informed consent;
* Capability to understand and comply with the protocol and signed informed consent document.
Exclusion Criteria
* Prior treatment with gemcitabine, carboplatin, cisplatin or iniparib
* Had not recovered to grade ≤1 from adverse events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v3.0 or to within 10% of baseline values due to investigational drugs or other medications administered more than 30 days prior to study enrollment;
* Major medical conditions that might have affected study participation (e.g. uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease);
* Concurrent radiation therapy intended to treat primary tumor not permitted throughout the course of the study; palliative radiation was acceptable;
* Leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention;
* Pregnancy or breastfeeding;
* Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Sedona, Arizona, United States
Research Site
Jonesboro, Arkansas, United States
Research Site
Alhambra, California, United States
Research Site
Bakersfield, California, United States
Research Site
Campbell, California, United States
Research Site
Fullerton, California, United States
Research Site
Lancaster, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Nothridge, California, United States
Research Site
Oxnard, California, United States
Research Site
Palo Alto, California, United States
Research Site
Pomona, California, United States
Research Site
Redondo Beach, California, United States
Research Site
San Francisco, California, United States
Research Site
Santa Barbara, California, United States
Research Site
Santa Maria, California, United States
Research Site
Sylmar, California, United States
Research Site
Vallejo, California, United States
Research Site
Westlake Village, California, United States
Research Site
Whittier, California, United States
Research Site
Denver, Colorado, United States
Research Site
Grand Junction, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Bonita Springs, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Ocoee, Florida, United States
Research Site
Orange Park, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Port Saint Lucie, Florida, United States
Research Site
Albany, Georgia, United States
Research Site
Athens, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Augusta, Georgia, United States
Research Site
Lawrenceville, Georgia, United States
Research Site
Macon, Georgia, United States
Research Site
Marietta, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Coeur d'Alene, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Overland Park, Kansas, United States
Research Site
Westwood, Kansas, United States
Research Site
Baltimore, Maryland, United States
Research Site
Chevy Chase, Maryland, United States
Research Site
Westminster, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Royal, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Rochester, Minnesota, United States
Research Site
Jackson, Mississippi, United States
Research Site
Columbia, Missouri, United States
Research Site
St Louis, Missouri, United States
Reserach Site
Billings, Montana, United States
Research Site
Grand Island, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Hooksett, New Hampshire, United States
Research Site
Morristown, New Jersey, United States
Research Site
Sparta, New Jersey, United States
Research Site
Santa Fe, New Mexico, United States
Research Site
Amsterdam, New York, United States
Research Site
East Setauket, New York, United States
Research Site
New York, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
Reserach Site
Durham, North Carolina, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Reserach Site
Columbia, South Carolina, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Memphis, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Bedford, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Fredericksburg, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Fairfax, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Roanoke, Virginia, United States
Research Site
Suffolk, Virginia, United States
Research Site
Kennewick, Washington, United States
Research Sites
Seattle, Washington, United States
Research Site
Vancouver, Washington, United States
Research Site
Yakima, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer. J Clin Oncol. 2014 Dec 1;32(34):3840-7. doi: 10.1200/JCO.2014.55.2984. Epub 2014 Oct 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20090301
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1119-8208
Identifier Type: OTHER
Identifier Source: secondary_id
EFC11486
Identifier Type: -
Identifier Source: org_study_id