A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: July 16, 2007
Last updated: June 11, 2009
Last verified: June 2009
A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients

Condition Intervention Phase
Advanced Solid Tumor
Drug: AZD2171
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Assessed at each visit for 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy, PK [ Time Frame: Assessed at each visit for 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2005
Study Completion Date: January 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD2171
    oral tablet
    Other Names:
    • cediranib

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • advanced solid tumors
  • life expectancy is 12 weeks or longer

Exclusion Criteria:

  • patient with uncontrolled brain metastases
  • patient with inappropriate laboratory test values
  • patient with poorly controlled hypertension
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00503477

Research Site
Shizuoka, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
Study Director: Jane Robertson AstraZeneca
Principal Investigator: Tomohide Tamura, MD National Cancer Centre Hospital, Tokyo
  More Information

Responsible Party: Jane Robertson, Medical Science Director,, AstraZeneca
ClinicalTrials.gov Identifier: NCT00503477     History of Changes
Other Study ID Numbers: D8480C00023 
Study First Received: July 16, 2007
Last Updated: June 11, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase I
solid tumor

Additional relevant MeSH terms:
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016