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Brief Title: A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS
Official Title: A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subjects With Advanced Cancers
Study ID: NCT03573310
Brief Summary: The purpose of the study is to identify the maximum tolerated dose (MTD) of JNJ-64619178 in participants with relapsed/refractory B cell non-Hodgkin lymphoma (NHL) or advanced solid tumors and also to identify the recommended Phase 2 dose(s) (RP2Ds) of JNJ-64619178 for NHL and advanced solid tumors (Part 1) and to confirm the tolerability of JNJ-64619178 in participants with lower risk myelodysplastic syndromes (MDS) (Part 2).
Detailed Description: The study is designed to determine the maximum tolerated dose (MTD) of JNJ-64619178, and to select a dose(s) and regimen(s) that may be used in future clinical development. Study evaluations will include safety, pharmacokinetics, biomarkers and efficacy evaluations (Disease Assessments). Adverse events will be evaluated throughout the study. The study is divided into 4 periods: a screening phase, a pharmacokinetic run-in phase, a treatment phase, and a post treatment follow-up phase. An end-of-treatment visit will be completed less than or equal (\<=) 30 days (+7 days) after the last dose of study drug or prior to the start of a new anticancer therapy, whichever comes first.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Florida Specialist and Cancer Institute, Sarasota, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Ohio State University, Columbus, Ohio, United States
University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
St. Paul's Hospital, Vancouver, British Columbia, Canada
University of Toronto, Toronto, Ontario, Canada
Universitaetsklinikum Duesseldorf, Düsseldorf, , Germany
Goethe Universität Frankfurt, Frankfurt/Main, , Germany
Universitaetsklinikum Leipzig, Leipzig, , Germany
Carmel Medical Center, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Tel Aviv Sourasky MC, Tel Aviv, , Israel
Hosp. Univ. Germans Trias I Pujol, Badalona, , Spain
Hosp. Univ. Vall D Hebron, Barcelona, , Spain
Hosp. Univ. Fund. Jimenez Diaz, Madrid, , Spain
Clinica Univ. de Navarra, Pamplona, , Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR