64264681LYM1001
Research type
Research Study
Full title
Protocol Title A Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
IRAS ID
273071
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen Cilag Internation NV
Eudract number
2019-003194-25
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
64264681LYM1001 is a Phase 1 study of JNJ-64264681 (the study drug) on participants with B-cell Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL). JNJ-64264681 is an oral inhibitor of Bruton’s tyrosine kinase (BTK). BTK is a protein involved in the growth of cancer cells in B cell lymphomas and leukemia. Drugs that inhibit BTK are currently available to treat these diseases. It is hoped that JNJ-64264681 will have fewer side effects than currently available BTK inhibitors. JNJ-64264681 has been tested for safety in healthy volunteers for up to 10 days in 1 clinical trial and for up to 1 month in animals.
Approximately 108 participants will be included in this two-part study. Part 1 of the study aims to find one or more “recommended doses” of JNJ-64264681. A “recommended dose” is a safe dose that can be used for further studies in participants with B-cell NHL, CLL or SLL. Part 1 also aims to find out how JNJ-64264681 is absorbed and cleared from the body and what its effects are on participants and on cancer cells. The main purpose of Part 2 is to continue to test the safety of the study drug using the recommended dose(s).
The first treatment group in the study will start with a dose within the range shown to be safe when dosed for up to 10 days in healthy participants. After review of the data at each dose level, it will be decided whether to increase the dose for the next group of participants. The dose a participant receives depends on when he/she is enrolled in the study.
Participants will take the study drug continuously as long as it is to their benefit. Participants will be carefully monitored throughout the study for any side-effects or changes in their condition.REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0633
Date of REC Opinion
20 Dec 2019
REC opinion
Unfavourable Opinion