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

Phase 2

• Conditions: Squamous Cell Carcinoma of the Lung; Gastric Cancer; Oesophageal Cancer; Breast Cancer
• Interventions: Drug: AZD 4547

• Registration Number: NCT01795768
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief 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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-02-18
• Study First Posted: 2013-02-21
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-15
• Primary Completion: 2014-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Treatment Arm	AZD 4547	16-24 patients per tumour group will be treated with AZD4547 administered 80mg twice daily, 2 weeks on, 1 week off in 21 days cycles.

Primary Outcome Measures

Name	Time	Method
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.	Baseline (tumour size, pERK), day 14(pERK), and week 8(tumour size)	A primary objective of the study is to collect serial research biopsies at baseline and on treatment with AZD4547, to assess the molecular changes that occur in the tumour in response to AZD4547 treatment and correlate with change in tumour size assessed at 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	Time measured from baseline to disease progression or death from any cause (approximately 3-9 months)
Disease control rate at eight weeks	Disease control rate will be calculated as the proportion of patients with CR/PR/SD at eight weeks from baseline
Response rate	Eight weeks from treatment initiation and then every 6 weeks thereafter	Response rate is assessed using RECIST 1.1 radiological response and centrally reviewed.
Safety and tolerability of AZD4547	Toxicity is assessed from consent until 30 days following treatment cessation

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 London and Surrey, Surrey, United Kingdom