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Completed

NCT Number: NCT00446342

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

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.

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Key information

Conditions

B-Lymphoid Malignancies Blood Protein Disorders Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SNS-032 Injection

Drug

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 outcomes

  1. To assess the safety and tolerability of SNS-032

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sunesis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Mar 12, 2007
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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