Status:
TERMINATED
Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
Lead Sponsor:
AstraZeneca
Conditions:
Cancer
Advanced Solid Malignancies
Eligibility:
All Genders
25-149 years
Phase:
PHASE1
Brief Summary
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 avail...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2015
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00979134
Start Date
October 21 2009
End Date
March 5 2015
Last Update
March 15 2019
Active Locations (29)
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1
Research Site
Stanford, California, United States, 94305
2
Research Site
Aurora, Colorado, United States, 80045
3
Research Site
New Haven, Connecticut, United States, 06520
4
Research Site
Detroit, Michigan, United States, 48201