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

Tumors Clinical Trial

Official title:

Phase 1 Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of SNS-032, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Select Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292864
• Other study ID #: SPO-0007
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2006
• Last updated: June 5, 2012
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2012
• Source: Sunesis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• SNS-032 Injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sunesis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Tolerability
Secondary	Pharmacokinetic profile
Secondary	Effect on QT interval
Secondary	Potential biomarkers
Secondary	Anti-tumor activity