A Phase I Study of Safety and Pharmacokinetics of Volitinib in Combination With Gefitinib in EGFR(+) NSCLC

Phase 1 Completed 64 enrolled Hutchison Medipharma Limited AstraZeneca · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1b, open-label, multicentre study of AZD6094 in combination with gefitinib in patients with epidermal growth factor receptor (EGFR) mutation positive (m+) and progressed on EGFR Tyrosine kinase inhibitor (TKI) treatment.

Timeline

Start: 2015-04
Primary completion: 2018-02-18
Completion: 2018-09-14

Publications

Yang JJ, Fang J, Shu YQ, Chang JH, Chen GY, He JX, Li W, Liu XQ, Yang N, Zhou C, Huang JA, Frigault MM, Hartmaier R, Ahmed GF, Egile C, Morgan S, Verheijen RB, Mellemgaard A, Yang L, Wu YL. A phase Ib study of the highly selective MET-TKI savolitinib plus gefitinib in patients with EGFR-mutated, MET-amplified advanced non-small-cell lung cancer. Invest New Drugs. 2021 Apr;39(2):477-487. doi: 10.1007/s10637-020-01010-4. Epub 2020 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefitinib	Small molecule	250 mg	Oral
Subject	Savolitinib	Small molecule	600 mg	Oral
Subject	Savolitinib	Small molecule	800 mg	Oral

A Phase I Study of Safety and Pharmacokinetics of Volitinib in Combination With Gefitinib in EGFR(+) NSCLC

Summary

Timeline

Publications

Drugs

Indications