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Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292864
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):
Sunesis Pharmaceuticals

Brief Summary:
The purpose of this study is to assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of SNS-032.

Condition or disease Intervention/treatment Phase
Tumors 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), preliminary evaluation of biomarkers to see how the levels of certain proteins change after administration of SNS-032; assessment of the effects of SNS-032 on QT interval.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of SNS-032, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Select Advanced Solid Tumors
Study Start Date : January 2006
Actual Study Completion Date : December 2007

Primary Outcome Measures :
  1. Safety
  2. Tolerability

Secondary Outcome Measures :
  1. Pharmacokinetic profile
  2. Effect on QT interval
  3. Potential biomarkers
  4. Anti-tumor activity

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Able to provide written informed consent
  • Advanced, progressing solid tumor that has no cure

    • In Stage 1, any advanced solid malignancy
    • In Stage 2, advanced breast cancer, melanoma, or non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  • Recovered from radiation therapy that may have been given in the last 21 days
  • Recovered from surgery

Exclusion Criteria:

  • Prior exposure to SNS-032 (previously known as BMS-387032)
  • Pregnant or breastfeeding
  • Women or male partners of women who are able to have children but are unwilling to use an approved, effective means of birth control
  • Took part in another clinical trial during the last 21 days
  • Abnormal lab values for serum potassium, hemoglobin, neutrophils, platelets, creatinine, AST, ALT, or total bilirubin
  • Brain metastases, if patient is not neurologically stable or has needed corticosteroids or anticonvulsants at anytime within the 28 day period before enrollment.
  • Other active malignancies
  • Prior pelvic radiation therapy to ≥ 25% of bone marrow reserve
  • Any other condition that would keep the patient from safely taking part in the clinical trial

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.

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 identifier (NCT number): NCT00292864

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United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
United States, California
University of California Davis Medical Center
Davis, California, United States, 95817
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Sunesis Pharmaceuticals
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Study Director: Daniel C. Adelman, MD Sunesis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sunesis Pharmaceuticals Identifier: NCT00292864    
Other Study ID Numbers: SPO-0007
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
Keywords provided by Sunesis Pharmaceuticals:
Advanced solid tumors
Additional relevant MeSH terms:
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