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.

First Received: July 16, 2007 Last Updated: June 11, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00503477

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Drug Information available for: Cediranib

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:

oral tablet

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

Keywords provided by AstraZeneca:

Japan
Phase I
solid tumor
AZD2171

ClinicalTrials.gov processed this record on September 11, 2009