Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

Stopped early · Phase 1

Conditions studied: Cancer, Advanced Solid Malignancies

In brief

This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

Key facts

Study ID

NCT00979134

Run by

AstraZeneca

People needed

95

Starts

2009-10-21

Expected to finish

2015-03-05

Last updated by the study team

2019-03-15

Who can join

Age: 25 and older, up to 149. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Minimum life expectancy of 12 weeks
• The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
• In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
• Expansion, 5 groups of advanced cancer
• Solid tumours,FGFR1 and/or FGFR2 gene amplified
• Squamous NSCLC, FGFR1 gene low \& high amplified
• Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low \& high amplified
• Aged at least 25 years

You may not qualify if…

• Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
• An inability to be able to take the study medication
• A bad reaction to AZD4547 or any drugs similar to it in structure or class.

Where it is running

• Research Site — Stanford, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Detroit, Michigan, United States
• Research Site — New York, New York, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Pierre-Bénite, France
• Research Site — Villejuif, France
• Research Site — Cologne, Germany
• Research Site — Frankfurt, Germany
• Research Site — Freiburg im Breisgau, Germany
• Research Site — Naples, Italy
• Research Site — Rozzano, Italy
• Research Site — Amsterdam, Netherlands
• Research Site — Rotterdam, Netherlands
• Research Site — Badajoz, Spain
• Research Site — Majadahonda, Spain
• Research Site — Valencia, Spain
• Research Site — Valencia, Spain
• Research Site — Birmingham, United Kingdom
• Research Site — Edinburgh, United Kingdom
• Research Site — Glasgow, United Kingdom
• Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

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