Status:
COMPLETED
Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies
Lead Sponsor:
Sunesis Pharmaceuticals
Conditions:
B-lymphoid Malignancies
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.
Detailed Description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.
Eligibility Criteria
Inclusion
- Cytologically or histologically confirmed chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), or multiple myeloma (MM).
- Evidence of relapsed disease
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Exclusion
- Prior treatment with SNS-032 injection (previously known as BMS-387032)
- Pregnant or breastfeeding
- Unwilling to use an approved, effective means of contraception according to the study site's standards
- Use of therapeutic anticoagulation agents
- Prior allogeneic bone marrow transplantation
- Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy within 21 days before the first dose; nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose.
- Prior pelvic radiation therapy or radiation to \> 25% of bone marrow reserve
- Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
- Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if the patient meets all study criteria.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00446342
Start Date
February 1 2007
End Date
March 1 2009
Last Update
April 11 2017
Active Locations (6)
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1
City of Hope
Duarte, California, United States, 91010
2
Stanford Cancer Center
Stanford, California, United States, 94305
3
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
4
Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201