Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001444
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Trial of Continuous Infusion UCN-01 in Patients With Refractory Neoplasms
Status:
COMPLETED
Status Verified Date:
2002-05
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:
This is a dosage escalation study to estimate the maximum tolerated dose of staurosporine analogue UCN-01 Groups of 3 to 6 patients receive a 72-hours intravenous continuous infusions of UCN-01 from day 1 to day 4 of each cycle the first cycle only and over 36-hours on subsequent cycles The side effects are allowed to disappear for up to 28 days This cycle is repeated after evaluations and follow-ups which are every 4 weeks as long as the patient benefits
Detailed Description:
Patients with relapsed or refractory neoplasms will be treated with escalating doses of UCN-017-hydroxystaurosporine a protein kinase C inhibitor which also may affect cyclin-dependent kinase activity given as a 72 hour infusion This trial will determine the toxicity associated with the maximally tolerated dose of this drug in patients for whom no other therapeutic approach is deemed to be more useful
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 |
|---|---|---|---|
| 95-C-0171 | None | None | None |