Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619236
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigators Choice in Participants With Platinum Resistant Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Open-label Study of Rinatabart Sesutecan Rina-S Versus Treatment of Investigators Choice IC in Patients With Platinum Resistant Ovarian Cancer
Status:
NOT_YET_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 phase 3 study will be conducted in different countries all over the world with about 530 participants
The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer
Treatment in this study could be Rina-S or it could be 1 of 4 chemotherapy agents that are considered standard medical care There is an equal 5050 chance of getting Rina-S or an approved chemotherapy agent as treatment in this study No one will know what treatment they are assigned to until the first dose
The study duration is anticipated to be up to 3 years All participants will receive active drug no one will be given placebo
The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer
Treatment in this study could be Rina-S or it could be 1 of 4 chemotherapy agents that are considered standard medical care There is an equal 5050 chance of getting Rina-S or an approved chemotherapy agent as treatment in this study No one will know what treatment they are assigned to until the first dose
The study duration is anticipated to be up to 3 years All participants will receive active drug no one will be given placebo
Detailed Description:
None
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