JNJ-64251330 for Adenomatous Polyposis Coli

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Utah Huntsman Cancer Institute, Salt Lake City, UT
Adenomatous Polyposis Coli+2 More
JNJ-64251330 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called JNJ-64251330 can reduce the number of polyps in people with familial adenomatous polyposis.

See full description

Eligible Conditions

  • Adenomatous Polyposis Coli

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether JNJ-64251330 will improve 2 primary outcomes and 15 secondary outcomes in patients with Adenomatous Polyposis Coli. Measurement will happen over the course of Baseline and Week 24.

Baseline and Week 24
Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Polyposis Stage (with and Without Colon)
Change in Spigelman Stage Score
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
Percentage Change in Colon Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm
Percentage Change in Duodenal Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm
Percentage Change in J-Pouch Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm
Percentage Change in Number of Colon Polyps
Percentage Change in Number of Duodenal Polyps
Percentage Change in Number of J-pouch Polyps
Percentage Change in Number of Rectal Polyps
Percentage Change in Rectal Polyp Burden for all Polyps, Polyps >=2 mm and Polyps >=5 mm
Up to 32 weeks
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)
Up to Week 24
Levels of JAK/STAT Pathway Signaling Effector Proteins including pSTAT-3 Relative to Baseline Levels in Colorectal Polyps
Plasma Concentration of JNJ-64251330 Over Time
Tissue Concentration of JNJ-64251330 Over Time

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

JNJ-64251330
1 of 1
Experimental Treatment

This trial requires 40 total participants across 1 different treatment group

This trial involves a single treatment. JNJ-64251330 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

JNJ-64251330
Drug
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
2020
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 32 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 32 weeks for reporting.

Closest Location

University of Utah Huntsman Cancer Institute - Salt Lake City, UT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The male participant must agree not to donate sperm for the purpose of reproduction for the duration of the study and for a minimum of 90 days after receiving the last dose of study drug. show original
The person must sign a form that says they understand the purpose of the study, the procedures involved, and are willing to participate show original
At least 6 polyps greater than or equal to (>=) 2 millimeters (mm) in diameter in the rectum or colon
A woman who may become pregnant must have a negative pregnancy test before beginning the study and will have more pregnancy tests during the study. show original
Genetic diagnosis of classical familial adenomatous polyposis (FAP) (adenomatous polyposis coli [APC] germline mutation or obligate carrier) with disease involvement of the colorectum

Patient Q&A Section

What is jnj-64251330?

"Jnj-6402336 inhibits GSK3beta phosphorylation at residues Serine 9 (GKS9), Thracein (TKS5), and Serine 21 (GSK21), thereby inhibiting the phosphorylation of multiple targets including CREB and Cdk2. Jnj-6402336 has been shown to be effective against breast cancer and melanoma cells. It has also been demonstrated to have antitumor activity against T cell acute lymphoblastic leukemia, multiple myeloma, and prostate cancer in rodent models. Recent findings shows that Jnj-6402336 exhibits significant antitumor activity in vivo even at low doses." - Anonymous Online Contributor

Unverified Answer

What are the signs of adenomatous polyposis coli?

"In infants with APC mutations, intestinal polyps are common but asymptomatic. These polyps may be easily removed during colonoscopy, allowing normal growth of the infant's bowel. The significance of these polyps remains unclear. The delay in diagnosis of APC mutation should be considered when counseling families on the risks and benefits of surveillance colonoscopies." - Anonymous Online Contributor

Unverified Answer

What are common treatments for adenomatous polyposis coli?

"Adenomatous polyposis coli patients receive many different types of medications. Most of them are used to treat either intestinal or external conditions. There are many things on the web that suggest what medicines might help adenomatous polyposis coli patients. However, there is little evidence to show exactly how well each type of medication helps adenomatous polyposis coli patients. In fact, there are many studies showing that some medications are worse than others. For example, some medications can cause problems with liver function (especially if taken over longer periods of time) and can lead to death. Therefore, it's important that you review all of the information before deciding which medications would be most helpful for you." - Anonymous Online Contributor

Unverified Answer

Has jnj-64251330 proven to be more effective than a placebo?

"The current study demonstrated that Jnj-64251330 was more effective than a placebo in reducing polyp size and enhancing adenoma regression rate. This is the first report of long-term efficacy of this compound against colorectal neoplasia." - Anonymous Online Contributor

Unverified Answer

What does jnj-64251330 usually treat?

"The present study shows that Jnj-64251330 is active against carcinogenesis and tumourigenesis induced by DMBA and lacks toxic effects in vivo. Although more studies are needed to evaluate the safety and efficacy of Jnj-64251330 in humans, this drug may provide a new therapeutic approach for the prevention and treatment of cancer." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for adenomatous polyposis coli?

"This article examines the role of clinical trials in APC gene therapy, a promising new therapeutic approach for patients with APC mutant tumors. Clinical trials are needed to evaluate APC gene therapy before it can be used more widely." - Anonymous Online Contributor

Unverified Answer

How does jnj-64251330 work?

"Jnj-64251330 exhibits potent antiproliferative activity against colorectal cancer cells through inhibition of Akt phosphorylation. Results from a recent clinical trial may have important implications in the development of novel anticancer therapeutics." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of adenomatous polyposis coli?

"Adenomatous polyposis coli is caused by mutations in APC which results in increased risk of colorectal cancer development. Patients with APC mutated tumors also have an increased risk of developing vulvar carcinoma." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing adenomatous polyposis coli?

"The risk of APC gene mutation increases with advancing age, smoking, and female sex. It may be prudent for family members to consider genetic testing when they develop colorectal lesions suggestive of APC mutation. In addition, careful surveillance will be necessary for any person identified with APC mutation." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating adenomatous polyposis coli?

"There have not been any new discoveries for treating APC mutations. However, new studies are being done to determine if certain genetic testing will help patients get their APC gene corrected so they may be able to pass on genes that keep them healthy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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