Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161025
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-11-27
Brief Title:
A Study of Raludotatug Deruxtecan R-DXd in Subjects With Platinum-resistant High-grade Ovarian Primary Peritoneal or Fallopian Tube Cancer
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 23 Multicenter Randomized Study of Raludotatug Deruxtecan R-DXd a CDH6-directed Antibody-drug Conjugate in Subjects With Platinum-resistant High-grade Ovarian Primary Peritoneal or Fallopian Tube Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian peritoneal or fallopian tube cancer
Detailed Description:
This study will focus on R-DXd in participants with platinum-resistant high-grade ovarian primary peritoneal or fallopian tube cancer R-DXd is an antibody-drug conjugate that specifically binds to CDH6 which is overexpressed in tumor cells The Phase 2 dose-optimization part of the study Part A intends to define the recommended dose based on safety and efficacy while the Phase 3 Part B part of the study will compare R-DXd with Investigators choice of chemotherapy and further evaluate efficacy
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 |
|---|---|---|---|
| GOG-3096 | OTHER | GOG | None |
| REJOICE-Ovarian01 | OTHER | None | None |
| ENGOT-ov77 | OTHER | None | None |