Text Size

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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00503477
First received: July 16, 2007
Last updated: June 11, 2009
Last verified: June 2009
History of Changes
  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
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
    • RECENTIN™
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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:
Japan
Phase I
solid tumor
AZD2171

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013