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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00446342
First received: March 8, 2007
Last updated: June 5, 2012
Last verified: June 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 21
Study Start Date: February 2007
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
Stanford Cancer Center
Stanford, California, United States, 94305
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

No publications provided by Sunesis Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00446342     History of Changes
Other Study ID Numbers: SPO-0009
Study First Received: March 8, 2007
Last Updated: June 5, 2012
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Mantle-Cell
Multiple Myeloma
Neoplasms
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Cyclin-Dependent Kinase Inhibitor Proteins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014