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

Sunesis Pharmaceuticals

Status and phase: Completed; Phase 1

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

Treatments: Drug: SNS-032 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446342

SPO-0009

Details and patient eligibility

About

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.

Full description

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Dose-escalation of SNS-032 injection

Experimental group

Description:

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.

Treatment:

Drug: SNS-032 Injection