Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081510
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2004-04-14
Brief Title:
Anastrozole Plus Lonafarnib SCH 66336 or Plus Placebo for the Treatment of Advanced Breast Cancer P03480
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib SCH 66336 or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Primary Objectives
To compare the activity progression-free survival PFS of anastrozole in combination with lonafarnib to that of anastrozole in combination with placebo in subjects with hormone-sensitive ADVANCED breast cancer
Secondary Objectives
To determine the effects of anastrozole in combination with lonafarnib on objective response duration of response overall survival and safety in subjects with advanced breast cancer To assess the exposure and pharmacokinetics of lonafarnib and anastrozole in the subject population
To compare the activity progression-free survival PFS of anastrozole in combination with lonafarnib to that of anastrozole in combination with placebo in subjects with hormone-sensitive ADVANCED breast cancer
Secondary Objectives
To determine the effects of anastrozole in combination with lonafarnib on objective response duration of response overall survival and safety in subjects with advanced breast cancer To assess the exposure and pharmacokinetics of lonafarnib and anastrozole in the subject population
Detailed Description:
None
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