Status:
COMPLETED
Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors
Lead Sponsor:
Sunesis Pharmaceuticals
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00292864
Start Date
January 1 2006
End Date
December 1 2007
Last Update
June 7 2012
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
2
University of California Davis Medical Center
Davis, California, United States, 95817
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215