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

Sunesis Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Tumors

Treatments

Drug: SNS-032 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00292864

SPO-0007

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.