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Report for Clinical Trial NCT02374645

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02374645 Non-Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Volitinib

Description: 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.
Type: Drug
Group Labels: 1

Volitinib (AZD6094) 600mg + gefitinib 250 mg

Name: gefitinib

Description: 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.
Type: Drug
Group Labels: 2

Volitinib (AZD6094) 600mg + gefitinib 250 mg Volitinib (AZD6094) 800mg + gefitinib 250 mg


Primary Outcomes

Description: the grade of AE event according to CTC AE 4.0

Measure: Number of adverse events and serious adverse events

Time: From ICF signed to within 28 days after the last dose

Secondary Outcomes

Description: Peak Plasma Concentration (Cmax)

Measure: The Pharmacokinetics (PK) profiles of AZD6094

Time: Cycle 1 Day1 and Day 15

Description: Area under the plasma concentration versus time curve (AUC)

Measure: The Pharmacokinetics (PK) profiles of AZD6094

Time: Cycle 1 Day1 and Day 15

Description: 6-months PFS, 12 months PFS and 24 month PFS

Measure: Progression-free survival (PFS)

Time: from enrolled until progression or death due to any cause, assessed up to 2 year

Description: CR+PR+SD

Measure: Disease control rate(DCR)

Time: 12 weeks and 24 weeks

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients who are harbouring an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X). --- L858R ---


2 L861Q

3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients who are harbouring an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X). --- L858R --- --- L861Q ---



HPO Nodes


HPO: