Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

Timeline

Start

2011-11

Primary completion

2013-08

Completion

2015-02

Outcome

Missed primary endpoint

registry NUMBER AZD4547: 1.8 months NUMBER Paclitaxel: 3.5 months NCT01457846 ↗

registry AZD4547 vs Paclitaxel; p = 0.9581; Hazard Ratio (HR) 1.57 (80% CI 1.12 to 2.21) NCT01457846 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fexagratinib	Small molecule	80 mg	Oral
Comparator	Paclitaxel	Small molecule	80 mg/m2	—

Indications