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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Tumors

Intervention / Treatment
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* Drug: SNS-032 Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SNS-032 Injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile |  |  | 
| Effect on QT interval |  |  | 
| Potential biomarkers |  |  | 
| Anti-tumor activity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Carcinoma, Adenocarcinoma, Tumor, Advanced solid tumors