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

June 5, 2012 updated by: Sunesis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Premiere Oncology of Arizona
    • California
      • Davis, California, United States, 95817
        • University of California Davis Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Tolerability

Secondary Outcome Measures

Outcome Measure
Pharmacokinetic profile
Effect on QT interval
Potential biomarkers
Anti-tumor activity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunesis Pharmaceuticals

Investigators

  • Study Director: Daniel C. Adelman, MD, Sunesis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPO-0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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