← Back to Search

Wnt Pathway Inhibitor

JNJ-64251330 for Adenomatous Polyposis

Dana Farber Cancer Institute, Boston, MA
JNJ-64251330Phase 1Waitlist AvailableResearch Sponsored by Janssen Research & Development, LLC

Study Summary

This trial will test if a new drug can help reduce the size of polyps in people with a genetic disorder that causes them to grow.

Eligible Conditions
  • Familial Adenomatous Polyposis (FAP)

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage Change from Baseline in Colorectal Polyp Burden for Polyps >=2 mm at Week 24
Percentage Change from Baseline in Colorectal Polyp Burden for all Polyps at Week 24
Secondary outcome measures
Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Polyposis Stage (with and Without Colon)
Change in Spigelman Stage Score
Levels of JAK/STAT Pathway Signaling Effector Proteins including pSTAT-3 Relative to Baseline Levels in Colorectal Polyps
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: JNJ-64251330Experimental Treatment1 Intervention
Participants will receive oral dose of JNJ-64251330 twice daily for 24 Weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-64251330
2021
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
963 Previous Clinical Trials
6,378,653 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
739 Previous Clinical Trials
3,958,437 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is JNJ-64251330 a risk-free therapy for individuals?

"The safety rating of JNJ-64251330 is a 1 because this clinical trial is in its first phase, so there are limited data points to assess both efficacy and security concerns."

Answered by AI

What is the objective of this investigation?

"This trial will measure the Percentage Change from Baseline in Colorectal Polyp Burden for all Polyps at Week 24 as its primary objective. Secondary outcomes include a report on the Percentage Change in Number of Rectal Polyps, the Change in Spigelman Stage Score (a classification system to assess risk of developing duodenal cancerr all Polyps at Week 24 as its primary objective. Secondary outcomes include a report on the Percentage Change in Number of Rectal Polyps, the Change in Spigelman Stage Score (a classification system to assess risk of developing duodenal cancer), and Percentage Change in Number of Duodenal Polyps."

Answered by AI

What is the aggregate headcount for participants in this research project?

"In order to fully commence this medical study, 40 participants that meet the predetermined qualifications must join in. Potential candidates can be found at City of Hope situated in Duarte or Mayo Clinic located in Phoenix."

Answered by AI

At what number of locations is this experimental endeavor taking place?

"6 medical facilities are participating in this trial, including City of Hope in Duarte, Mayo Clinic in Phoenix and University of Miami located also at Miami. Additionally, there are 6 other clinical sites that are partaking."

Answered by AI

Are there still opportunities to participate in the research?

"Clinicaltrials.gov has revealed that this medical test is actively seeking participants since its inception on November 10th 2021. The trial was most recently updated on December 1st 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis
2021. "A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05014360.
~14 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top