ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00503477
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : June 12, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: AZD2171 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : October 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : January 2009

Intervention Details:
  • Drug: AZD2171
    oral tablet
    Other Names:
    • cediranib
    • RECENTIN™


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

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


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:   20 Years to 75 Years   (Adult, Older Adult)
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

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

Responsible Party: Jane Robertson, Medical Science Director,, AstraZeneca
ClinicalTrials.gov Identifier: NCT00503477     History of Changes
Other Study ID Numbers: D8480C00023
First Posted: July 18, 2007    Key Record Dates
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