- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00502060
Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer
May 13, 2009 updated by: AstraZeneca
A Phase I Open-Label Study to Assess the Safety, Tolerability and PK of Ascending Multiple Oral Doses of AZD2171 When co-Administered With Fixed Multiple Oral Doses of ZD1839 (250mg or 500mg Once Daily) in Patients With Advanced Cancer
Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
65
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands
- Research Site
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Nijmegen, Netherlands
- Research Site
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Utrecht, Netherlands
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- tumor progressed on standard therapy or ineligible for standard therapy
- life expectancy of 12 weeks or more
- WHO performance status 0-2
Exclusion Criteria:
- History of active interstitial lung disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839
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Secondary Outcome Measures
Outcome Measure |
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to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM, AstraZeneca
- Principal Investigator: G Giaccone, Prof, Vrije Universiteit Medical Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
July 13, 2007
First Submitted That Met QC Criteria
July 13, 2007
First Posted (Estimate)
July 17, 2007
Study Record Updates
Last Update Posted (Estimate)
May 14, 2009
Last Update Submitted That Met QC Criteria
May 13, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D8480C00004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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