Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of SNS-032.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunesis Pharmaceuticals
• Treatments: Cyclin-Dependent Kinase Inhibitor Proteins

Criteria

Inclusion Criteria:

• Able to provide written informed consent

• Advanced, progressing solid tumor that has no cure

• In Stage 1, any advanced solid malignancy

• In Stage 2, advanced breast cancer, melanoma, or non-small cell lung cancer (NSCLC)

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2

• Recovered from radiation therapy that may have been given in the last 21 days

• Recovered from surgery

Exclusion Criteria:

• Prior exposure to SNS-032 (previously known as BMS-387032)

• Pregnant or breastfeeding

• Women or male partners of women who are able to have children but are unwilling to use an approved, effective means of birth control

• Took part in another clinical trial during the last 21 days

• Abnormal lab values for serum potassium, hemoglobin, neutrophils, platelets, creatinine, AST, ALT, or total bilirubin

• Brain metastases, if patient is not neurologically stable or has needed corticosteroids or anticonvulsants at anytime within the 28 day period before enrollment.

• Other active malignancies

• Prior pelvic radiation therapy to ≥ 25% of bone marrow reserve

• Any other condition that would keep the patient from safely taking part in the clinical trial

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.