Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060151
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2003-05-06
Brief Title:
GW786034 in Treating Patients With Advanced Solid Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Open Label Multiple Dose Dose Escalation Study OF GW786034 In Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE-100231 | None | None | None |
| CASE-CWRU-100231 | None | None | None |
| GSK-VEG10003 | None | None | None |
| GSK-RM20020034502 | None | None | None |
| CWRU-GLAX-1Y02 | None | None | None |
| CWRU-1Y02 | None | None | None |