A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Patients With Advanced or Refractory Solid Tumors or Lymphoma

NCT01962532 ↗

Phase 1 Completed 19 enrolled Janssen Research & Development, LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine a dose for future development and to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy profiles of JNJ-42756493 in Japanese and other Asian patients with advanced or refractory solid tumors or lymphoma.

Timeline

Start: 2013-08-21
Primary completion: 2016-01-28
Completion: 2016-01-28

Publications

Results Nishina T, Takahashi S, Iwasawa R, Noguchi H, Aoki M, Doi T. Safety, pharmacokinetic, and pharmacodynamics of erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in patients with advanced or refractory solid tumors. Invest New Drugs. 2018 Jun;36(3):424-434. doi: 10.1007/s10637-017-0514-4. Epub 2017 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erdafitinib	Small molecule	2 mg	Oral
Subject	Erdafitinib	Small molecule	4 mg	Oral
Subject	Erdafitinib	Small molecule	6 mg	Oral
Subject	Erdafitinib	Small molecule	10 mg	Oral
Subject	Erdafitinib	Small molecule	12 mg	Oral

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 in Patients With Advanced or Refractory Solid Tumors or Lymphoma

Summary

Timeline

Publications

Drugs

Indications