Ignite Creation Date:
2024-05-05 @ 11:50 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01430585
Status:
TERMINATED
Last Update Posted:
2014-08-12
First Post:
2011-08-18
Brief Title:
Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An Open-Label Randomised Phase 1b2 Study Of PF-04691502 In Combination With Letrozole Compared With Letrozole Alone In Patients With Estrogen Receptor Positive Her-2 Negative Early Breast Cancer
Status:
TERMINATED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PF-04691502 is an inhibitor of PI3K and mTOR kinase Published data support the hypothesis that a PI3KmTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and restore hormone sensitivity in high risk high Ki-67 patient population of hormone-sensitive breast cancers In addition Ki-67 a marker of cellular proliferation could be used to select those patients who benefit from treatment with a PI3K-pathway inhibitor
Detailed Description:
The study was prematurely discontinued on 09Oct2012 due to the tolerability findings in 2 clinical studies testing PF-04691502 that have prompted the Sponsor to re-evaluate the strategic goals of the program In the study B1271003 an unexpected frequency of severe skin toxicity was observed and in the study B1271004 5 cases of drug induced pneumonitis were reported
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