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

This study is ongoing, but not recruiting participants.

First Received: October 21, 2005 Last Updated: April 8, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00243347

Purpose

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.

Condition	Intervention	Phase
Carcinoma Non-Small-Cell Lung Carcinoma Head and Neck Neoplasms	Drug: AZD2171	Phase I

MedlinePlus related topics: Cancer Head and Neck Cancer Lung Cancer

Drug Information available for: Cediranib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	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)

Further study details as provided by AstraZeneca:

Estimated Enrollment:	26
Study Start Date:	December 2005
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

oral tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243347

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Oncology Medical Sciences Director, MD

AstraZeneca

More Information

Additional Information:

AstraZeneca Information - Outside of the US This link exits the ClinicalTrials.gov site

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca ( Jane Robertson, Medical Science Director )
Study ID Numbers:	D8480C00015
Study First Received:	October 21, 2005
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00243347 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

RECENTIN

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Head and Neck Neoplasms

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Head and Neck Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009