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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00292864
First received: February 15, 2006
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Tumors
Drug: SNS-032 Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:
  • Safety
  • Tolerability

Secondary Outcome Measures:
  • Pharmacokinetic profile
  • Effect on QT interval
  • Potential biomarkers
  • Anti-tumor activity

Estimated Enrollment: 25
Study Start Date: January 2006
Study Completion Date: December 2007
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.

  Eligibility

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

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.

  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: NCT00292864

Locations
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
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Sunesis Pharmaceuticals
Investigators
Study Director: Daniel C. Adelman, 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: NCT00292864     History of Changes
Other Study ID Numbers: SPO-0007
Study First Received: February 15, 2006
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunesis Pharmaceuticals:
Cancer
Carcinoma
Adenocarcinoma
Tumor
Advanced solid tumors

Additional relevant MeSH terms:
Cyclin-Dependent Kinase Inhibitor Proteins
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014