A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis
Completed · Phase 1
Conditions studied: Adenomatous Polyposis Coli
In brief
The purpose of this study is to determine the effect of JNJ-64251330 in participants with Familial Adenomatous Polyposis (FAP) on colorectal polyp burden (sum of the polyp diameters).
Key facts
- Study ID
- NCT05014360
- Run by
- Janssen Research & Development, LLC
- People needed
- 42
- Starts
- 2021-11-10
- Expected to finish
- 2023-02-15
- Last updated by the study team
- 2023-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Genetic diagnosis of classical familial adenomatous polyposis (FAP) (adenomatous polyposis coli [APC] germline mutation or obligate carrier) with disease involvement of the colorectum
- At least 6 polyps greater than or equal to (>=) 2 millimeters (mm) in diameter in the rectum or colon
- A female participant of childbearing potential must have a negative highly sensitive pregnancy test at screening and within 72 hours prior to the first dose of study drug and must agree to further pregnancy tests during the study
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug
- Must sign an informed consent form (ICF) indicating he or she understands the purpose of the study and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the participant's disease
You may not qualify if…
- Use of non-steroidal anti-inflammatory drugs (example, aspirin, ibuprofen) exceeding 5 days per month or exceeding the nonprescription dose, unless the participant completes a 4-week washout period prior to the first dose of study drug
- Treatment with other FAP-directed drug therapy (including sulindac or celecoxib), unless completes a 4-week washout period prior to the first dose of study drug
- History of human immunodeficiency virus (HIV)
- History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof
- A history of, or ongoing, chronic or recurrent infectious disease including latent or active tuberculosis (TB)
Where it is running
- City of Hope — Duarte, California, United States
- University of Miami — Miami, Florida, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Hopital Edouard Herriot - CHU Lyon — Lyon, France
- APHM Hopital Timone — Marseille, France
- Universitatsklinikum Bonn — Bonn, Germany
- Academisch Medisch Centrum Universiteit van Amsterdam — Amsterdam, Netherlands
- Pan American Center for Oncology Trials LLC — Río Piedras, Puerto Rico
- Seoul National University Hospital — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
- Hosp. Clinic I Provincial de Barcelona — Madrid, Spain
- Clinica Univ. de Navarra — Pamplona, Spain
Full record on ClinicalTrials.gov
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