Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors
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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 |
- Safety
- Tolerability
- Pharmacokinetic profile
- Effect on QT interval
- Potential biomarkers
- Anti-tumor activity
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2006 |
| Study Completion Date: | December 2007 |
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 |
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| 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 | |
| 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 May 22, 2013