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

Phase 1

Completed

• Conditions: Tumors

• Registration Number: NCT00292864
• Lead Sponsor: Sunesis Pharmaceuticals

Brief 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.

Detailed Description

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body), preliminary evaluation of biomarkers to see how the levels of certain proteins change after administration of SNS-032; assessment of the effects of SNS-032 on QT interval.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-16
• Study Completion: 2007-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerability
Safety

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile
Effect on QT interval
Potential biomarkers
Anti-tumor activity

Trial Locations

Locations (6)

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

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States