GW786034 in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00060151
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Determine the safety and tolerability of GW786034 in patients with advanced solid tumors.
* Determine the maximum tolerated dose of this drug in these patients.
* Determine the pharmacokinetics of this drug in these patients.
* Determine the clinical response in patients treated with this drug.
* Evaluate the effect of this drug on biomarkers of angiogenesis activity in order to estimate activity and to determine the minimum biologically active dose in these patients.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and toxicity assessed weekly during treatment
- Secondary Outcome Measures
Name Time Method Disease response every 9 weeks
Trial Locations
- Locations (2)
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Duke Comprehensive Cancer Center🇺🇸Durham, North Carolina, United States