NCT00446342

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sunesis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	SNS-032 Injection	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

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-12-01
• Completion: 2009-03-01
• First posted: 2007-03-12
• Last updated: 2017-04-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study