Overview

Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sunesis Pharmaceuticals
Treatments:
Cyclin-Dependent Kinase Inhibitor Proteins
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.