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Spots Global Cancer Trial Database for A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS

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Trial Identification

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

Interventions

JNJ-64619178

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Janssen Research & Development, LLC Clinical Trial

Affiliation: Janssen Research & Development, LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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