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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446342
• Other study ID #: SPO-0009
• Status: Completed
• Phase: Phase 1
• First received: March 8, 2007
• Last updated: April 7, 2017
• Start date: February 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2017
• Source: Sunesis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Winship Cancer Institute at Emory University	Atlanta	Georgia
United States	Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	City of Hope	Duarte	California
United States	Hackensack University Medical Center at the Cancer Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center, University of Texas	Houston	Texas
United States	Stanford Cancer Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunesis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of SNS-032		1 year
Secondary	To characterize the pharmacokinetic profile of SNS-032		1 year
Secondary	Identify a recommended Phase 2 dose and schedule of administration		1 year