Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02684032
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2016-02-10
Brief Title:
A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With PalbociclibLetrozole Or PalbociclibFulvestrant In Women With Metastatic Breast Cancer
Sponsor:
Celcuity Inc
Organization:
Celcuity Inc
Study Overview
Official Title:
PHASE 1B STUDY TO ASSESS THE SAFETY TOLERABILITY AND CLINICAL ACTIVITY OF GEDATOLISIB IN COMBINATION WITH PALBOCICLIB AND EITHER LETROZOLE OR FULVESTRANT IN WOMEN WITH METASTATIC OR LOCALLY ADVANCEDRECURRENT BREAST CANCER MBC
Status:
COMPLETED
Status Verified Date:
2022-07
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 multicenter open label Phase 1b study in patients with mBC This study will have a dose escalation to identify the maximum tolerated dose MTD of the combination of gedatolisib plus palbociclibfulvestrant and gedatolisib plus palbociclibletrozole and expansion to estimate the objective response rate OR of the combination of gedatolisib plus palbociclibletrozole or palbociclibfulvestrant
Detailed Description:
This is a multicenter open label continuous Phase 1b study in patients with MBC This study will have a dose escalation and expansion The dose escalation will identify the maximum tolerated dose MTD of the combination of gedatolisib plus palbociclibfulvestrant and gedatolisib plus palbociclibletrozole The expansion will estimate the objective response rate OR of the combination of gedatolisib plus palbociclibletrozole and the combination of gedatolisib plus palbociclibfulvestrant
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