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Tyrosine Kinase Inhibitor

Treatment (erlotinib hydrochloride) for Adenomatous Polyposis

Phase 2
Waitlist Available
Led By Niloy J Samadder
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Study Summary

This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligible Conditions
  • Adenomatous Polyposis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Percent Change in Duodenal Polyp Burden
Number of Participants With Grade 2/3 Adverse Event (AE)
Secondary outcome measures
Lower Gastrointestinal Tract
Absolute Change in Lower Gastrointestinal Polyp Number
Fibromatosis, Aggressive
+4 more
Other outcome measures
Change in Differentially Expressed Genes of Duodenal Polyps and Uninvolved Tissue
EGFR and Wnt Gene Expression
Immune Response Signaling in Duodenal Adenomas and Uninvolved Tissue

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (erlotinib hydrochloride)Experimental Treatment2 Interventions
Patients receive erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib Hydrochloride
2010
Completed Phase 2
~2850
Erlotinib
2011
Completed Phase 4
~2290

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,926,087 Total Patients Enrolled
Niloy J SamadderPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
3,019 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
2017. "Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02961374.
~6 spots leftby Apr 2025
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