Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies

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 escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.

Detailed Description
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Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.

Official Title
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Phase 1 Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of Intravenously Administered SNS-032 Injection, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Advanced B-Lymphoid Malignancies

Conditions
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B-lymphoid Malignancies, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma

Intervention / Treatment
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* Drug: SNS-032 Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cytologically or histologically confirmed chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), or multiple myeloma (MM). Evidence of relapsed disease Measurable disease Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Exclusion Criteria: Prior treatment with SNS-032 injection (previously known as BMS-387032) Pregnant or breastfeeding Unwilling to use an approved, effective means of contraception according to the study site's standards Use of therapeutic anticoagulation agents Prior allogeneic bone marrow transplantation Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy within 21 days before the first dose; nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose. Prior pelvic radiation therapy or radiation to > 25% of bone marrow reserve Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if the patient meets all study criteria.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose-escalation of SNS-032 injection<br>Patients escalated to MTD starting in Cohort 1 of 15 mg/m2 of SNS-032 injection, with 1.5-fold increase each cohort and a maximum loading dose increase of 10 mg/m2. Each dose cohort will have a minimum of 3 patients each with advanced CLL or MM. Dose escalation continues in the absence of Cycle 1 DLT criteria until an MTD is achieved for each disease type to a maximum of 7 cohorts at a high dose of 70 mg/m2. Stage 2 tests at MTD in larger group. | Drug: SNS-032 Injection<br>* Stage 1: Escalating doses of SNS-032 on days 1, 8 and 15 per 28 day cycle Stage 2: Same as stage 1 except SNS-032 administered at the maximum tolerated dose established in stage 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of SNS-032 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetic profile of SNS-032 |  | 1 year | 
| Identify a recommended Phase 2 dose and schedule of administration |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leukemia, lymphoma, myeloma, non-Hodgkin's, CLL, MCL, MM, Phase 1, hematological malignancy