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

Completed · Phase 1

Conditions studied: Tumors

In brief

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.

Key facts

Study ID

NCT00292864

Run by

Sunesis Pharmaceuticals

People needed

25

Starts

2006-01-01

Expected to finish

2007-12-01

Last updated by the study team

2012-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Premiere Oncology of Arizona — Scottsdale, Arizona, United States
• University of California Davis Medical Center — Davis, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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