NCT01795768

Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

To assess the activity of the FGFR inhibitor AZD4547 in patients with FGFR1 or FGFR2 amplified breast, squamous lung and stomach cancer whose cancers have progressed following previous chemotherapy

Detailed description

Primary endpoint \- To assess anti-tumour activity as change in tumour size at 8 weeks and the correlation with change in tumour ERK1/2 phosphorylation at day 10-14. Secondary endpoints * Objective response rate to AZD4547 in all patients and in each tumour group * Safety and tolerability of AZD4547 in all patients * Disease control rate at 8 weeks * Progression free survival in all patients and in each tumour group

Conditions

• Gastric Cancer
• Oesophageal Cancer
• Breast Cancer
• Squamous Cell Carcinoma of the Lung

Interventions

Type	Name	Description
DRUG	AZD 4547

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2015-09-01
• First posted: 2013-02-21
• Last updated: 2013-03-15

Locations

1 site across 1 country: United Kingdom