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

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ClinicalTrials.gov Identifier: NCT00446342
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
B-lymphoid Malignancies Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Multiple Myeloma Drug: SNS-032 Injection Phase 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2007
Primary Completion Date : December 2008
Study Completion Date : March 2009


Arm Intervention/treatment
Experimental: Dose-escalation of 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.
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




Primary Outcome Measures :
  1. To assess the safety and tolerability of SNS-032 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To characterize the pharmacokinetic profile of SNS-032 [ Time Frame: 1 year ]
  2. Identify a recommended Phase 2 dose and schedule of administration [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sunesis Pharmaceuticals:
leukemia
lymphoma
myeloma
non-Hodgkin's
CLL
MCL
MM
Phase 1
hematological malignancy

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