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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00060151 |
RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of GW786034 in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: pazopanib hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Open Label, Treatment |
Official Title: | A Phase I, Open Label, Multiple Dose, Dose Escalation Study OF GW786034 In Patients With Solid Tumors |
Study Start Date: | December 2002 |
OBJECTIVES:
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.
Patients receive oral GW786034 twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 2-6 patients receive escalating doses of GW786034 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 21 days.
PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No untreated leptomeningeal or brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation (e.g., warfarin at therapeutic doses)
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Afshin Dowlati, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000299531, CASE-100231, CASE-CWRU-100231, CWRU-1Y02, CWRU-GLAX-1Y02, GSK-RM2002/00345/02, GSK-VEG10003 |
Study First Received: | May 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00060151 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |