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
Overview
- Phase
- Phase 1
- Intervention
- SNS-032 Injection
- Conditions
- B-lymphoid Malignancies
- Sponsor
- Sunesis Pharmaceuticals
- Enrollment
- 21
- Locations
- 6
- Primary Endpoint
- To assess the safety and tolerability of SNS-032
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Dose-escalation of SNS-032 injection
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.
Intervention: SNS-032 Injection
Outcomes
Primary Outcomes
To assess the safety and tolerability of SNS-032
Time Frame: 1 year
Secondary Outcomes
- To characterize the pharmacokinetic profile of SNS-032(1 year)
- Identify a recommended Phase 2 dose and schedule of administration(1 year)