Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT07213804
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
FRAmework-01: A Two-Part Phase 3 Study of LY4170156 Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and LY4170156 Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.
Status:
RECRUITING
Status Verified Date:
2025-12
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:
FRAmework-01
Brief Summary:
This is a clinical study that has two parts. It is testing a potential new medicine called LY4170156 for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if LY4170156 works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-522255-25-00 | CTIS | None | View | |
| J5E-MC-JZXB | OTHER | Eli Lilly and Company | View | |
| GOG-3133 | OTHER | Gynecologic Oncology Group | View | |
| ENGOT-ov97/GINECO-NOGGO | OTHER | European Network of Gyneaecological Oncological Trial Groups | View | |
| APGOT-OV17 | OTHER | Asia-Pacific Gynecologic Oncology Trials Group | View |