Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
NCT ID: NCT00979134
Last Updated: 2019-03-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
95 participants
INTERVENTIONAL
2009-10-21
2015-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part A
Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD)
AZD4547
Single dose is followed by washout 5-10 days before multiple dose
Part B
Dose expansion phase, at the RD defined in Part A
AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
Part C
Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A
AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
Interventions
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AZD4547
Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
AZD4547
Patients start at a dose of 80 mg twice daily, with no washout
AZD4547
Single dose is followed by washout 5-10 days before multiple dose
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
25 Years
149 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Fabrice André, Dr
Role: PRINCIPAL_INVESTIGATOR
Institut de cancérologie Gustave Roussy
Donal Landers, Dr
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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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
Napoli, , 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
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Newcastle upon Tyne, , United Kingdom
Research Site
Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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D2610C00001
Identifier Type: -
Identifier Source: org_study_id
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