This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 13, 2007
Last updated: May 13, 2009
Last verified: May 2009
Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer

Condition Intervention Phase
Advanced Tumor Drug: AZD2171 Drug: ZD1839 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days

Estimated Enrollment: 65
Study Start Date: August 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00502060

Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Utrecht, Netherlands
Sponsors and Collaborators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: G Giaccone, Prof Vrije Universiteit Medical Centre
  More Information Identifier: NCT00502060     History of Changes
Other Study ID Numbers: D8480C00004
Study First Received: July 13, 2007
Last Updated: May 13, 2009

Keywords provided by AstraZeneca:
Phase I
solid tumor

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017