Trial intelligence / Profile preview

ASP8273 in EGFR-mutated NSCLC

NCT02192697Phase 2

Key facts

Status: Terminated
Start: Jan 2014
Primary completion: Jan 2016
Countries: 3
Sponsor: Astellas Pharma
Modality: Small Molecules

Drugs: naquotinib
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label trial of naquotinib in non-small cell lung cancer (NSCLC) (3 arms), sponsored by Astellas Pharma. Primary endpoints: Dose Limiting Toxicities and Overall Response Rate at Week 24. Started Jan 2014; status: terminated.

Design

3 arms

Study design: Non-randomizedOpen-label

Phase I Dose Escalation
Dose escalation of ASP8273
Phase I EGFR-T790M
ASP8273 in T790M+ patients
Phase II
ASP8273 at RP2D

Who it enrols

Patients with histologically confirmed NSCLC harboring EGFR activating mutations (del ex19, L858R, G719X, or L861Q) who have progressed on prior EGFR-TKIs. Phase II specifically requires the T790M mutation.

Endpoints

Primary

Dose Limiting ToxicitiesUp to Day 23
Overall Response RateWeek 24

Secondary

Adverse EventsUp to 18 months
Laboratory TestsUp to 18 months
Vital SignsUp to 18 months
12-lead ECGUp to 18 months
Plasma concentrations of unchanged ASP8273Up to Day 1 of Cycle 3
Urine concentrations of unchanged ASP8273Up to Day 1 of Cycle 3
Overall Response RateUp to 18 months
Disease Control RateUp to 18 months

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