Status:
COMPLETED
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologic...
Eligibility Criteria
Inclusion
- Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
- ECOG performance status of 0, 1, or 2
- Adequate hematological status
- Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
- 18 years of age or older
- Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
- For phase 1b portion only: metastatic breast cancer
Exclusion
- Hematologic malignancies
- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
- Myocardial infarction within 6 months of study day 1, unstable angina, congestive heart failure with NYHA \> class II, uncontrolled hypertension
- Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
- Major surgery within 1 month of study day 1
- History of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary cancer with no known active disease present and no curative treatment administered for the last 3 years
- History of seizure disorder or currently on anti-seizure medication
- Systemic chemotherapy or radiation therapy within 28 days of study day 1
- Antibody therapy for treatment of underlying malignancy within 1 month of study day 1
- Evidence of liver disease shown by elevated enzymes
- Evidence of renal disease shown by serum creatinine \> 1.5 x upper limit of normal
- Currently receiving platelet of GCF support for any medical condition
- Concurrent use of herbal medications taken with the intent to treat cancer
- Enrolled in or not yet completed at least 30 days since ending other investigational device or drug study
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00298675
Start Date
March 1 2006
End Date
May 1 2011
Last Update
August 2 2012
Active Locations (3)
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1
Research Site
New Haven, Connecticut, United States
2
Research Site
Houston, Texas, United States
3
Research Site
San Antonio, Texas, United States