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 |
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.
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.
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
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