Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05501886
Status:
RECRUITING
Last Update Posted:
2023-08-01
First Post:
2022-08-12
Brief Title:
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HRHER2- Breast Cancer VIKTORIA-1
Sponsor:
Celcuity Inc
Organization:
Celcuity Inc
Study Overview
Official Title:
Phase 3 Open-Label Randomized Study Comparing Gedatolisib Combined With Fulvestrant With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive HER2-Negative Advanced Breast Cancer Previously Treated With a CDK46 Inhibitor in Combination wNon-Steroidal Aromatase Inhibitor Therapy
Status:
RECRUITING
Status Verified Date:
2023-07
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:
VIKTORIA-1
Brief Summary:
This is a Phase 3 open-label randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HRHER2- breast cancer following progression on or after CDK46 and aromatase inhibitor therapy
Detailed Description:
This is a Phase 3 open-label randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with advanced inoperable or metastatic Hormone Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative HRHER2- breast cancer following progression on or after CDK46 and aromatase inhibitor therapy Gedatolisib is an intravenously administered pan-PI3KmTOR inhibitor Palbociclib is a CDK46 inhibitor Fulvestrant is a selective estrogen receptor degrader SERD Subjects will be assessed for PIK3CA status and then randomized to treatment arms according to their confirmed PIK3CA mutation status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2021-005235-24 | EUDRACT_NUMBER | None | None |