Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001341
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Trial of ZD1694 TOMUDEX an Inhibitor of Thymidylate Synthase in Pediatric Patients With Advanced Neoplastic Disease
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Trial of ZD1694 TOMUDEX Registered Trademark an Inhibitor of Thymidylate Synthase in Pediatric Patients With Advanced Neoplastic Disease
Status:
COMPLETED
Status Verified Date:
2000-08
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:
Thymidylate synthase TS an enzyme which acts by utilizing 510-CH2FH4 in the reductive methylation of deoxyuridylate dUMP is required for the de novo synthesis of thymidylate and is a potential chemotherapeutic target ZD1694 is a new quinazolone folate analog that directly inhibits TS This phase I trial and pharmacokinetic study will describe and define the toxicities determine the MTD and describe the plasma pharmacokinetics of ZD1694 in pediatric patients with refractory cancer The starting dose for this trial will be 20 mgm2 administered as a 15 minute IV infusion every 21 days
Detailed Description:
Thymidylate synthase TS an enzyme which acts by utilizing 510-CH2FH4 in the reductive methylation of deoxyuridylate dUMP is required for the de novo synthesis of thymidylate and is a potential chemotherapeutic target ZD1694 is a new quinazolone folate analog that directly inhibits TS This phase I trial and pharmacokinetic study will describe and define the toxicities determine the MTD and describe the plasma pharmacokinetics of ZD1694 in pediatric patients with refractory cancer The starting dose for this trial will be 20 mgm2 administered as a 15 minute IV infusion every 21 days
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 |
|---|---|---|---|
| 93-C-0210 | None | None | None |