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

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Multiple Myeloma; B-lymphoid Malignancies
• Interventions: Drug: SNS-032 Injection

• Registration Number: NCT00446342
• Lead Sponsor: Sunesis Pharmaceuticals

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-08
• Study First Submitted QC: 2007-03-08
• Study First Posted: 2007-03-12
• Primary Completion: 2008-12
• Study Completion: 2009-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose-escalation of SNS-032 injection	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.

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of SNS-032	1 year

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic profile of SNS-032	1 year
Identify a recommended Phase 2 dose and schedule of administration	1 year

Trial Locations

Locations (6)

City of Hope; 🇺🇸 Duarte, California, United States

Winship Cancer Institute at Emory University; 🇺🇸 Atlanta, Georgia, United States

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

MD Anderson Cancer Center, University of Texas; 🇺🇸 Houston, Texas, United States

Hackensack University Medical Center at the Cancer Center; 🇺🇸 Hackensack, New Jersey, United States

Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States