Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT06243458
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-22
First Post:
2024-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RVU120 for Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms
Sponsor:
GCP-Service International West GmbH
Organization:
Study Overview
Official Title:
A Phase II, Open-label, Multicenter Study of Orally Administered RVU120 for the Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms (MDS)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
(MDS)
Brief Summary:
This study will evaluate orally administered RVU120, a novel small molecule Cyclin-dependent Kinase (CDK) 8/19 inhibitor, in terms of erythroid hematologic improvement (HI-E) and safety in participants with lower-risk myelodysplastic syndrome (MDS). Responding patients are eligible to continue treatment until loss of response/disease progression.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|---|
| EUCT Number 2023-509947-29 | OTHER | CTIS / EMA | View |