A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
2 other identifiers
interventional
136
1 country
6
Brief Summary
The purpose of the study is to assess the safety and establish the maximum tolerated dose (MTD) of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors. 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2007
Longer than P75 for phase_1
6 active sites
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
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 12, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 10, 2016
June 1, 2016
2 years
January 12, 2007
June 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
safety and efficacy
ongoing
Response rate (CR + PR)
every 2 cycles
Study Arms (4)
1
EXPERIMENTALBSI-201 + topotecan
2
EXPERIMENTALBSI-201 + temozolomide
3
EXPERIMENTALbsi-201 + gemcitabine
4
EXPERIMENTALbsi-201 + carboplatin/paclitaxel
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years old with a histologically or cytologically documented, advanced solid tumor
- 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
You may not qualify if:
- Subject enrolled in another investigational device or drug trial, or is receiving other investigational agents
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (6)
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
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 12, 2007
First Posted
January 17, 2007
Study Start
January 1, 2007
Primary Completion
January 1, 2009
Study Completion
October 1, 2012
Last Updated
June 10, 2016
Record last verified: 2016-06