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

June 11, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Advanced Solid Tumor

Intervention / Treatment

Drug: AZD2171

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Shizuoka, Japan
    - Research Site
  - Tokyo, Japan
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability Time Frame: Assessed at each visit for 4 weeks	Assessed at each visit for 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
efficacy, PK Time Frame: Assessed at each visit for 4 weeks	Assessed at each visit for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Tomohide Tamura, MD, National Cancer Centre Hospital, Tokyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria