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

This study is ongoing, but not recruiting participants.

First Received: February 15, 2006 Last Updated: July 20, 2007 History of Changes

Sponsored by:	Sunesis Pharmaceuticals
Information provided by:	Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00292864

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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

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
Estimated 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

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 National Clinical Trials Identifier (NCT ID):

Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66.

Study ID Numbers:	SPO-0007
Study First Received:	February 15, 2006
Last Updated:	July 20, 2007
ClinicalTrials.gov Identifier:	NCT00292864 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunesis Pharmaceuticals:

Cancer
Carcinoma
Adenocarcinoma
Tumor
Advanced solid tumors

Study placed in the following topic categories:

Cyclin-Dependent Kinase Inhibitor Proteins
Adenocarcinoma
Protein Kinase Inhibitors
Carcinoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cyclin-Dependent Kinase Inhibitor Proteins
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009