A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
NCT ID: NCT00422682
Last Updated: 2016-06-10
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
PHASE1
136 participants
INTERVENTIONAL
2007-01-31
2012-10-31
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 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
NCT00687687
Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial
NCT01593228
Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients
NCT01204125
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
NCT05625412
A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)
NCT04111458
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
BSI-201 + topotecan
bsi-201 + topotecan
21 day cycle
2
BSI-201 + temozolomide
bsi-201 + temozolomide
28 day cycle
3
bsi-201 + gemcitabine
bsi-201 + gemcitabine
28 day cycle
4
bsi-201 + carboplatin/paclitaxel
bsi-201 + carboplatin/paclitaxel
21 day cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bsi-201 + topotecan
21 day cycle
bsi-201 + temozolomide
28 day cycle
bsi-201 + gemcitabine
28 day cycle
bsi-201 + carboplatin/paclitaxel
21 day cycle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (without granulocyte colony-stimulating factor \[G-CSF\] support within 2 weeks of study day 1); platelet count ≥ 100.0 x 10\^9/L (without transfusion within 2 weeks of study day 1); and hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)
* At least a 14-day period from end of last dose of chemotherapy received
* Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1
Exclusion Criteria
* Hematological malignancies
* Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
* History of seizure disorder
* Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) \> class II, or uncontrolled hypertension
* Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose for port maintenance allowed)
* Specified concomitant medications
* Serum creatinine \> 1.5 x upper limit of normal (ULN)
* Elevated liver enzymes (AST/ALT) \> 2.5 x ULN, or \> 5.0 x ULN if secondary to liver metastases; alkaline phosphatase \> 2.5 x ULN or \> 5.0 x ULN if secondary to liver or bone metastases; total bilirubin \> 1.5 x ULN
* Radiation therapy within 14 days of study day 1
* Antibody therapy for the treatment of an underlying malignancy within 14 days of study day 1
* Concurrent radiation therapy is not permitted throughout the course of the study
18 Years
ALL
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.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
New Haven, Connecticut, United States
Research Site
Detroit, Michigan, United States
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20060102
Identifier Type: OTHER
Identifier Source: secondary_id
TCD11484
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.