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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00502060
First received: July 13, 2007
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502060

Locations
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Utrecht, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: G Giaccone, Prof Vrije Universiteit Medical Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00502060     History of Changes
Other Study ID Numbers: D8480C00004
Study First Received: July 13, 2007
Last Updated: May 13, 2009
Health Authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)

Keywords provided by AstraZeneca:
Phase I
AZD2171
ZD1839
solid tumor

Additional relevant MeSH terms:
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013