Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006375
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2000-10-04
Brief Title:
LY293111 in Treating Patients With Advanced Solid Tumors
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Clinical and Pharmacokinetic Evaluation of LY293111 in Patients With Solid Tumors Protocol H6H-MC-JEAI
Status:
COMPLETED
Status Verified Date:
2013-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of LY293111 in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of LY293111 in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of LY293111 in patients with advanced solid tumors II Determine the safety profile and pharmacokinetics of this regimen in these patients III Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study Patients receive oral LY293111 twice daily Treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of LY293111 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicity Additional patients are treated at the MTD Patients are followed at 30 days
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive oral LY293111 twice daily Treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of LY293111 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicity Additional patients are treated at the MTD Patients are followed at 30 days
PROJECTED ACCRUAL Approximately 24 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 |
|---|---|---|---|
| NCI-G00-1862 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068249 | REGISTRY | None | None |
| MSKCC-H6H-MC-JEAI | None | None | None |