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Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502060
First Posted: July 17, 2007
Last Update Posted: May 14, 2009
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.
Information provided by:
AstraZeneca
July 13, 2007
July 17, 2007
May 14, 2009
August 2004
June 2006   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00502060 on ClinicalTrials.gov Archive Site
to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days
Same as current
Not Provided
Not Provided
 
Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Tumor
  • Drug: AZD2171
  • Drug: ZD1839
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 2006
June 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00502060
D8480C00004
Yes
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: G Giaccone, Prof Vrije Universiteit Medical Centre
AstraZeneca
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP