A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Participants With Advanced Cancers



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/9/2018
Start Date:July 13, 2018
End Date:December 10, 2021
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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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

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.

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.

Inclusion Criteria:

- B cell non-Hodgkin lymphoma (NHL) or solid tumor

- 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
We found this trial at
3
sites
6001 Dodge Street
Omaha, Nebraska 68198
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Omaha, NE
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600 North Cattlemen Road
Sarasota, Florida 34232
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Sarasota, FL
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Toronto,
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