Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04609826
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2020-09-30
Brief Title:
A Study of JNJ-74856665 in Participants With Acute Myeloid Leukemia AML or Myelodysplastic Syndrome MDS
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 1 FIH Dose Escalation Study of JNJ-74856665 Dihydroorotate Dehydrogenase DHODH Inhibitor Alone or in Combination in Participants With AML or MDS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
DHODH
Brief Summary:
The purpose of this study is to determine the safety tolerability maximum tolerated doses MTDs and recommended Phase 2 doses RP2Ds of JNJ-74856665 as monotherapy andor in combinations
Detailed Description:
This is first-in-human FIH Phase 1 dose escalation study of JNJ-74856665 alone or in combination with Azacitidine or Venetoclax in participants with Acute Myeloid Leukemia AML or Myelodysplastic Syndrome MDS Participants with Chronic Myelomonocytic Leukemia CMML are also eligible and will either receive JNJ-74856665 as monotherapy or in combination with Azacitidine AML is a heterogeneous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells myeloid blasts in the peripheral blood bone marrow and other tissues and is the second most common form of leukemia MDS are a heterogeneous group of malignant hematopoietic stem cell disorders that are characterized by cytopenias myeloid dysplasia and a risk of transformation to AML JNJ-74856665 is an orally bioavailable potent and selective dihydroorotate dehydrogenase DHODH inhibitor that binds to the enzymes ubiquinone binding site promoting AMLMDS differentiation as well as cell cycle arrest and apoptosis Azacitidine 5-azacytidine is a nucleoside metabolic inhibitor that has been US Food and Drug Administration-approved for several MDS subtypes Venetoclax VEN is a BCL-2 inhibitor that can restore activation of apoptosis in malignant cells the survival of which often depends on dysregulation of this pathway The study is divided into 3 periods a Screening Phase within 28 days before the first dose of study drug a Treatment Phase first dose of study drug until the completion of the end-of-treatment visit and a Post-treatment Follow-up Phase up to the end of study participation or end of study The end of study is defined as the last study assessment for the last participant in the study Total duration of study is up to 2 years and 10 months Efficacy safety pharmacokinetics PK and biomarkers will be assessed at specified time points during this study Participants safety and study conduct will be monitored throughout the study
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002375-35 | EUDRACT_NUMBER | None | None |
| 74856665AML1001 | OTHER | Janssen Research Development LLC | None |