Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052273
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-01-24
Brief Title:
LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Dose Escalation Study With Oral LY317615 in Combination With Capecitabine in Advanced Cancer Patients
Status:
COMPLETED
Status Verified Date:
2012-08
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 LY317615 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining LY317615 with capecitabine may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining LY317615 with capecitabine in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and the recommended phase II dose of LY317615 and capecitabine in patients with advanced solid tumors
Determine the safety profile of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine preliminarily the antitumor activity of this regimen in these patients
Determine the effects of LY317615 on potential angiogenic surrogate markers in these patients
OUTLINE This is a dose-escalation study
Patients receive oral LY317615 daily on days 1-14 course 1 only Beginning with course 2 patients receive oral LY317615 daily on days 1-21 and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of LY317615 and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the recommended phase II dose
Patients are followed at 30 days after the last dose of study drug
PROJECTED ACCRUAL A total of 12-36 patients will be accrued for this study
Determine the maximum tolerated dose and the recommended phase II dose of LY317615 and capecitabine in patients with advanced solid tumors
Determine the safety profile of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine preliminarily the antitumor activity of this regimen in these patients
Determine the effects of LY317615 on potential angiogenic surrogate markers in these patients
OUTLINE This is a dose-escalation study
Patients receive oral LY317615 daily on days 1-14 course 1 only Beginning with course 2 patients receive oral LY317615 daily on days 1-21 and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of LY317615 and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the recommended phase II dose
Patients are followed at 30 days after the last dose of study drug
PROJECTED ACCRUAL A total of 12-36 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0206061 | None | None | None |
| LILLY-H6Q-MC-JCAH | None | None | None |
| NCI-G02-2132 | None | None | None |