Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05645536
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-04
First Post:
2022-12-01
Brief Title:
Safety Extension Study for Subjects With HR HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
Sponsor:
Tolmar Inc
Organization:
Tolmar Inc
Study Overview
Official Title:
Open-label Safety Extension Study for Subjects With HR HER2-Negative Breast Cancer Who Have Completed the OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer OVELIA Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
TOL2506A OVELIA is a Phase 3 single arm open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR HER2-negative breast cancer and men with HR breast cancer The TOL2506A-EXT study described here is a safety extension study to assess and collect long-term data on the ongoing safety and tolerability of TOL2506 in combination with tamoxifen or an AI for up to 4 years
Detailed Description:
None
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