The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer

August 9, 2013 updated by: AstraZeneca

An Exploratory, Open-Lael Study to Assess the Effects of AZD2171 on Tumors and Biomarkers in Patients With Previously Untreated or Recurrent Non-small Cell Lung Cancer (NSCLC) or Patients With Metastatic or Recurrent Head and Neck Cancer (HNC)

This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.

Study Overview

Status

Completed

Conditions

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

Spain
- - Barcelona, Spain
    - Research Site
United States
- Texas
  - Houston, Texas, United States
    - 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable stage IIIb or IV non-small cell lung cancer (NSCLC)
At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET Scan
Considered suitable for treatment of NSCLC with no prior biological or immunological therapy for disease
Or considered suitable for treatment for metastatic or recurrent HNC with no prior biological or immunological therapy for disease

Exclusion Criteria:

NSCLC: Have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of AZD2171
HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of AZD2171
Untreatable, unstable brain or meningeal metastases.
Abnormal liver and kidney blood chemistries
History of poorly controlled hypertension with resting blood pressure of >150/100
Recent (< 14 days) major surgery or a surgical incision not fully healed
Diabetes patients with type I insulin dependent diabetes or poorly controlled type II
Significant hemorrhage or hemoptysis
Presence of necrotic/hemorrhagic tumor or metastases

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	Measure Description	Time Frame
Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) Time Frame: Randomisation until Day 22	Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)*100	Randomisation until Day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Arterial Blood Pressure (MAP) Time Frame: Randomisation until Day 22	Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).	Randomisation until Day 22

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

Study Director: AstraZeneca Oncology Medical Sciences Director, MD, AstraZeneca

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

December 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

October 21, 2005

First Submitted That Met QC Criteria