Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04021368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2019-07-12
Brief Title:
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
Sponsor:
Ryvu Therapeutics SA
Organization:
Ryvu Therapeutics SA
Study Overview
Official Title:
A Phase Ib Study of RVU120 SEL120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
This first-in-human study will evaluate RVU120 SEL120 a novel small molecule CDK819 inhibitor in patients with Acute Myeloid Leukemia AML or High-risk Myelodysplastic Syndrome HR-MDS in terms of selection of the recommended dose for further clinical development and assessment of safety tolerability preliminary anti-leukemic activity as well as pharmacokinetic and pharmacodynamic profiles
Detailed Description:
The study will determine the recommended phase II dose RP2D and safety of RVU120 SEL120 given as monotherapy over a range of dose-levels following a closely controlled dose escalation study design
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