Status:
COMPLETED
A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 cy...
Eligibility Criteria
Inclusion
- ≥ 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00422682
Start Date
January 1 2007
End Date
October 1 2012
Last Update
June 10 2016
Active Locations (6)
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1
Research Site
New Haven, Connecticut, United States
2
Research Site
Detroit, Michigan, United States
3
Research Site
New York, New York, United States
4
Research Site
Philadelphia, Pennsylvania, United States