Sarasota, Florida 34232


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03573310


Primary Contact:

Study Director
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC

Study Contact
Phone: 844-434-4210
Email: JNJ.CT@sylogent.com


Backup Contact:

N/A


Location Contact:

Sarasota, Florida 34232
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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