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

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. Identifier: NCT00502060
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : May 14, 2009
Information provided by:

Brief Summary:
Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer

Condition or disease Intervention/treatment Phase
Advanced Tumor Drug: AZD2171 Drug: ZD1839 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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
Study Start Date : August 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Primary Outcome Measures :
  1. 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 :
  1. to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00502060     History of Changes
Other Study ID Numbers: D8480C00004
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 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