Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003706
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
1999-11-01
Brief Title:
LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase I Pharmacokinetic Trial of LY231514 Administered Intravenously Every 3 Weeks in Advanced Cancer Patients With Varying Degrees of Renal Function
Status:
COMPLETED
Status Verified Date:
2012-06
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 Chemotherapy drugs may have different effects in patients with different degrees of kidney function
PURPOSE Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function
PURPOSE Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function
Detailed Description:
OBJECTIVES I Determine the toxic effects and maximum tolerated dose MTD of LY231514 in patients with metastatic or locally advanced solid tumors and varying degrees of renal function II Determine the recommended dose for LY231514 in this patient population III Examine the effects of renal dysfunction on the pharmacokinetics of LY231514 in this patient population IV Examine the relationship between impaired renal function drug exposure and drug effects in these patients V Gather data for development of a LY231514 dosing nomogram based on renal function VI Collect preliminary data regarding antitumor effects of LY231514 in this patient population
OUTLINE This is an open label dose escalation study Patients are stratified according to renal function Group 1 consists of patients with normal renal function and groups 2 3 and 4 consist of patients with mild moderate and severe renal impairment All patients receive LY231514 IV over 10 minutes every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated with escalating doses of LY231514 within each treatment group If dose limiting toxicity DLT is observed in 1 of 3 patients at a given dose level then 3 additional patients are studied The maximum tolerated dose is defined as the dose level at which less than 2 of 6 patients experience DLT Patients are followed until death
PROJECTED ACCRUAL Up to 50 patients will be accrued for this study
OUTLINE This is an open label dose escalation study Patients are stratified according to renal function Group 1 consists of patients with normal renal function and groups 2 3 and 4 consist of patients with mild moderate and severe renal impairment All patients receive LY231514 IV over 10 minutes every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated with escalating doses of LY231514 within each treatment group If dose limiting toxicity DLT is observed in 1 of 3 patients at a given dose level then 3 additional patients are studied The maximum tolerated dose is defined as the dose level at which less than 2 of 6 patients experience DLT Patients are followed until death
PROJECTED ACCRUAL Up to 50 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 |
|---|---|---|---|
| P30CA054174 | NIH | None | None |
| UTHSC-9785011141 | OTHER | None | None |
| LILLY-H3E-MC-JMAWa | OTHER | None | None |
| SACI-IDD-97-29 | OTHER | None | None |
| NCI-V98-1500 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |