Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060645
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2003-05-08
Brief Title:
Safety Study of AP23573 in Patients With Advanced Refractory or Recurrent Malignancies 8669-013COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase I Sequential Cohort Dose Escalation Trial to Determine the Safety Tolerability and Maximum Tolerated Dose of Daily x 5 Administration of AP23573 an mTOR Inhibitor in Patients With Refractory or Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2015-08
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:
Phase 1 trial to determine the safety tolerability and maximum tolerated dose MTD of AP23573 in patients with refractory or recurrent malignancies including myeloma and lymphoma
Detailed Description:
The primary objectives of the study are to determine the safety tolerability and MTD of AP23573 when administered once daily for 5 days to be repeated every 2 weeks two 2-week courses equals 1 cycle The secondary objectives of the study are to characterize the pharmacokinetic profile of AP23573 to evaluate potential pharmacodynamic markers of AP23573 and to obtain preliminary information on the antineoplastic activity of AP23573
Protocol Outline This is a dose-escalation study Patients receive AP23573 over 30 minutes by intravenous infusion once daily for 5 days to be repeated every 2 weeks If tolerated a total of at least 2 cycles will be administered 8-week treatment period Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Protocol Outline This is a dose-escalation study Patients receive AP23573 over 30 minutes by intravenous infusion once daily for 5 days to be repeated every 2 weeks If tolerated a total of at least 2 cycles will be administered 8-week treatment period Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| AP23573-02-102 | None | None | None |