Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT01294735
Status:
COMPLETED
Last Update Posted:
2012-08-15
First Post:
2011-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)
Sponsor:
Merck Sharp & Dohme LLC
Organization:
Study Overview
Official Title:
A Phase I Study of MK-4827 in Combination With Temozolomide in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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:
This is a non-randomized two-part study of MK-4827 given with temozolomide in participants with advanced cancer. In Part A of the study, the dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of MK-4827 when combined with temozolomide will be found by increasing the MK-4827 dose level in successive cohorts. In Part B of the study, participants with advanced glioblastoma multiforme and advanced melanoma will be enrolled to further evaluate the tolerability and efficacy of the MK-4827 + temozolomide combination.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: