Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365853
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-10
Brief Title:
A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
Sponsor:
ImmunoGen Inc
Organization:
ImmunoGen Inc
Study Overview
Official Title:
A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Patients With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine MIRV-related ocular treatment-emergent adverse events TEAEs and assess prophylaxis strategies in all participants symptomatic and asymptomatic undergoing prospective ophthalmic evaluation with recurrent ovarian cancer participants with either platinum-sensitive ovarian cancer PSOC or platinum-resistant ovarian cancer PROC with high folate receptor alpha FRĪ± expression
Detailed Description:
Participants will be randomized 11 to 1 of 2 ocular adverse event AE risk mitigation strategy arms primary prophylactic steroid eye drops versus primary prophylactic vasoconstricting eye drops
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 |
|---|---|---|---|
| 2023-505617-24-00 | CTIS | None | None |