Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours (FGFR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01795768|
Recruitment Status : Unknown
Verified March 2013 by Royal Marsden NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : February 21, 2013
Last Update Posted : March 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Oesophageal Cancer Breast Cancer Squamous Cell Carcinoma of the Lung||Drug: AZD 4547||Phase 2|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2015|
Experimental: Single Treatment Arm
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.
Drug: AZD 4547
- 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. [ Time Frame: 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.
- Response rate [ Time Frame: Eight weeks from treatment initiation and then every 6 weeks thereafter ]Response rate is assessed using RECIST 1.1 radiological response and centrally reviewed.
- Progression free survival [ Time Frame: Time measured from baseline to disease progression or death from any cause (approximately 3-9 months) ]
- Disease control rate at eight weeks [ Time Frame: Disease control rate will be calculated as the proportion of patients with CR/PR/SD at eight weeks from baseline ]
- Safety and tolerability of AZD4547 [ Time Frame: Toxicity is assessed from consent until 30 days following treatment cessation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795768
|Contact: Angela Gillbanks||+44(0)firstname.lastname@example.org|
|Contact: Elizabeth Smyth, MB MRCP MSc||+44(0)email@example.com|
|Royal Marsden NHS Foundation Trust||Recruiting|
|London and Surrey, Surrey, United Kingdom, SM2 5PT|
|Contact: Angela Gillbanks +44(0)2086613156 firstname.lastname@example.org|
|Principal Investigator: David Cunningham, MD FRCP|
|Sub-Investigator: Nicholas Turner, MA MRCP PhD|
|Sub-Investigator: Sanjay Popat, BSc MBBS MRCP PhD|
|Sub-Investigator: Elizabeth Smyth, MB MRCP MSc|
|Principal Investigator:||David Cunningham, MD FRCP||Royal Marsden NHS Foundation Trust|