A Phase 1 Study of JNJ-74856665 in AML or MDS patients
Research type
Research Study
Full title
A Phase 1, First in Human (FIH), Dose Escalation Study of JNJ-74856665 (dihydroorotate dehydrogenase [DHODH] Inhibitor) Alone or in Combination in Participants with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
IRAS ID
288214
Contact name
Hariet Walter
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-002375-35
Duration of Study in the UK
3 years, 10 months, 21 days
Research summary
Acute myeloid leukemia (AML) is a disease causing uncontrolled growth of blood cells (myeloid blasts) in blood, bone marrow and other tissue. This is the second most common form of leukemia. Myelodysplastic syndromes (MDS) are group of blood cell disorders characterised by the blood-forming cells in the bone marrow becoming abnormal. This leads to low numbers of one or more types of blood cells.
The drug being studied is called JNJ-74856665 which is an investigational (or experimental) drug that has not been used in humans before but has only been studied in test tubes and animals. JNJ-74856665 is an oral drug called a DHODH inhibitor.
The purpose of this study is to see if there are doses of JNJ-74856665 given alone or in combination with azacitidine (AZA) that are both safe and effective in treating patients with AML and MDS. This study will also look at the effects on AML and MDS and any side effects. Another purpose is to find out how long JNJ-74856665 stays in and acts on the body and how the body responds to it. Patients will be provided study drug as long as they receive benefit from the drug.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/1090
Date of REC Opinion
12 Oct 2020
REC opinion
Favourable Opinion