Study of Intravenously Administered SNS-032 in Patients With Advanced B-Lymphoid Malignancies - Full Text View

Sponsored by:	Sunesis Pharmaceuticals
Information provided by:	Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00446342

Purpose

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.

Condition	Intervention	Phase
B-Lymphoid Malignancies Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Multiple Myeloma	Drug: SNS-032 Injection	Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:

To assess the safety and tolerability of SNS-032 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To characterize the pharmacokinetic profile of SNS-032 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Identify a recommended Phase 2 dose and schedule of administration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental All patients entered into 1 drug treatment arm for CLL or MM	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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446342

Locations

United States, California
Stanford Cancer Center
Stanford, California, United States, 94305
City of Hope
Duarte, California, United States, 91010
United States, Georgia
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, New Jersey
Hackensack University Medical Center at the Cancer Center
Hackensack, New Jersey, United States, 07601
United States, Texas
MD Anderson Cancer Center, University of Texas
Houston, Texas, United States, 77230

Sponsors and Collaborators

Sunesis Pharmaceuticals

Investigators

Study Director:

Glenn Michelson, MD

Sunesis Pharmaceuticals

More Information

Responsible Party:	Sunesis Pharmaceuticals, Inc. ( Glenn Michelson, MD )
Study ID Numbers:	SPO-0009
Study First Received:	March 8, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00446342
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunesis Pharmaceuticals:

leukemia
lymphoma
myeloma
non-Hodgkin's
CLL

MCL
MM
Phase 1
hematological malignancy

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Hematologic Diseases
Blood Protein Disorders
Leukemia, B-cell, chronic
Lymphoma, Mantle-Cell
Blood Coagulation Disorders
Vascular Diseases
Cyclin-Dependent Kinase Inhibitor Proteins
Paraproteinemias
Hemostatic Disorders

Mantle cell lymphoma
Multiple Myeloma
Leukemia
Lymphatic Diseases
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases

Enzyme Inhibitors
Cardiovascular Diseases
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009