NCT02699606

A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma

A Phase 2a Study to Evaluate The Clinical Efficacy of JNJ-42756493, A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Patients With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Gastric Cancer, Esophageal Cancer Or Cholangiocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a molecularly-defined subset of Asian participants with non-small-cell lung cancer (NSCLC), urothelial cancer, esophageal cancer and cholangiocarcinoma.

Detailed description

This is an open-label (all people know the identity of the intervention), multicenter, phase 2 study to evaluate the clinical efficacy, safety and pharmacokinetics of erdafitinib in Asian participants with advanced NSCLC, urothelial cancer, esophageal cancer and cholangiocarcinoma.

Conditions

• Neoplasm

Interventions

Type	Name	Description
DRUG	Erdafitinib	Participants will receive 8 mg of erdafitinib, once daily with option to up-titrate to 9 mg.

Timeline

• Start date: 2016-07-08
• Primary completion: 2021-10-12
• Completion: 2024-03-15
• First posted: 2016-03-04
• Last updated: 2025-04-27

Locations

6 sites across 3 countries: China, South Korea, Taiwan