CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 64 enrolled
Drug / intervention
Volitinib +1 moredrug
Likely dose
Volitinib 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02374645
NCT02374645Phase 1Completed

A Phase Ib, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumour Activity of Volitinib in Combination With Gefitinib in Patients With Epidermal Growth Factor Receptor-mutated Non-small Cell Lung Cancer Who Have Progressed on Epidermal Growth Factor Receptor Inhibitor Treatment

Hutchison Medipharma Limited·interventional·Posted Mar 2, 2015·Updated Apr 24, 2020

In Brief

A Phase 1 clinical trial evaluating Volitinib and gefitinib for Non-Small Cell Lung Cancer. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
CollaboratorsAstraZeneca

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2, 2015
Enrollment StartApr 1, 2015
Primary CompletionFeb 18, 2018
Study CompletionSep 14, 2018
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 11.3 years ago

Interventions

Volitinibdrug

600mg or 800mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

gefitinibdrug

250mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.