Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001573
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy
Status:
COMPLETED
Status Verified Date:
2000-02
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:
A dose escalation scale consisting of 5 dosage levels is being used to determine the maximum tolerated dose MTD of SU101 A minimum of 3 and a maximum of 6 patients will be enrolled at each dose level MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity
Each treatment cycle is 21 days Patients receive a 96 hour continuous IV infusion of SU101 on days 1-4
Each treatment cycle is 21 days Patients receive a 96 hour continuous IV infusion of SU101 on days 1-4
Detailed Description:
SU101 is a member of a novel class of antineoplastic agents platelet-derived growth factor PDGF receptor inhibitors Preclinical data suggests that SU101 might be an effective agent against neuroglial tumors as well as a variety of sarcomas A pediatric phase I trial of SU101 in children with these malignancies will be conducted to find the maximum tolerated dose of SU101 and define the toxicity profile of this agent In addition we will define the pharmacokinetics of SU101 and its active metabolite SU0020 in pediatric patients and gather preliminary information regarding response
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 |
|---|---|---|---|
| 97-C-0087 | None | None | None |