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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503477
First Posted: July 18, 2007
Last Update Posted: June 12, 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
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Assessed at each visit for 4 weeks ]

Secondary Outcome Measures:
  • efficacy, PK [ Time Frame: Assessed at each visit for 4 weeks ]

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
    • RECENTIN™
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00503477


Locations
Japan
Research Site
Shizuoka, Japan
Research Site
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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
First Submitted: July 16, 2007
First Posted: July 18, 2007
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Japan
Phase I
solid tumor
AZD2171

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