Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086125
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2004-06-24
Brief Title:
Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies 8669-024COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase II Study of AP23573 an mTOR Inhibitor in Patients With Relapsed or Refractory Hematologic 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:
The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies
Detailed Description:
The primary objective of the trial is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies by evaluating the response rates as defined for the individual malignancy categories Secondary objectives include evaluating time to disease progression progression-free survival and duration of response evaluating the pharmacokinetic and pharmacodynamic characteristics of AP23573 describing health-related quality of life measurements and exploring the safety and tolerability of AP23573 at the specified dose level
Protocol Outline Open label non-randomized parallel cohorts of five disease-specific cohorts with a minimum of 21 patients per cohort Each patient receives a fixed dose of AP23573 administered intravenously IV over 30 minutes daily for five days QDx5 to be repeated every 2 weeks
Protocol Outline Open label non-randomized parallel cohorts of five disease-specific cohorts with a minimum of 21 patients per cohort Each patient receives a fixed dose of AP23573 administered intravenously IV over 30 minutes daily for five days QDx5 to be repeated every 2 weeks
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 |
|---|---|---|---|
| AP23573-04-201 | None | None | None |