drugset / Trial / NCT02273362

Erlotinib Hydrochloride in Preventing Liver Cancer in Patients With Cirrhosis of the Liver

NCT02273362 ↗

Phase 1/2 Completed 25 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelPrevention

Summary

This pilot phase I/II trial studies the best dose of erlotinib hydrochloride and to see how well it works in preventing liver cancer in patients with scarring (cirrhosis) of the liver. Erlotinib hydrochloride may help to inhibit the development of fibrous tissue and prevent liver cancer from forming in patients with cirrhosis of the liver.

Timeline

Start
2014-11-24
Primary completion
2020-02-11
Completion
2022-03-10

Outcome

Met primary endpoint

paper A ≥50% reduction phospho-EGFR immunohistochemical staining in the liver was observed in a minimum of 40% of participants (predetermined threshhold) at each of the dose levels. PMID 39131140 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 25 mg Oral
Subject Erlotinib Small molecule 50 mg Oral
Subject Erlotinib Small molecule 75 mg Oral