Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors
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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.
Condition or disease
Drug: SNS-032 Injection
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.
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
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.