Non Hodgkin Lymphoma Clinical Trial

A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS

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).

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

B cell non-Hodgkin lymphoma (NHL) or solid tumors, or lower risk MDS
At least 1 measurable site of disease for B cell-NHL and solid tumors
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Adequate organ function
Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and prior to the first dose of study drug. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug

Exclusion Criteria:

History of, or known, central nervous system (CNS) involvement
Prior solid organ transplantation
Either of the following: a) Received an autologous stem cell transplant less than or equal (<=) 9 months before the first dose of study drug B) Prior treatment with allogenic stem cell transplant
History of malignancy (other than the disease under study) within 3 years before the first administration of study drug. Exceptions include squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
Known allergies, hypersensitivity, or intolerance to JNJ-64619178 or its excipient

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT03573310

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 18 Locations for this study

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Florida Specialist and Cancer Institute
Sarasota Florida, 34232, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Ohio State University
Columbus Ohio, 43210, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Toronto
Toronto , M5G1Z, Canada
St. Paul's Hospital
Vancouver , V6E 1, Canada
Universitaetsklinikum Duesseldorf
Düsseldorf , 40225, Germany
Goethe Universität Frankfurt
Frankfurt/Main , 60590, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Carmel Medical Center
Haifa , 34362, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Tel Aviv Sourasky MC
Tel Aviv , 64239, Israel
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Virgen Del Rocio
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT03573310

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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