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

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. Identifier: NCT00243347
Recruitment Status : Completed
First Posted : October 24, 2005
Results First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma Non-Small-Cell Lung Carcinoma Head and Neck Neoplasms Drug: AZD2171 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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).

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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00243347

United States, Texas
Research Site
Houston, Texas, United States
Research Site
Barcelona, Spain
Sponsors and Collaborators
Study Director: AstraZeneca Oncology Medical Sciences Director, MD AstraZeneca

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00243347     History of Changes
Other Study ID Numbers: D8480C00015
First Posted: October 24, 2005    Key Record Dates
Results First Posted: October 17, 2013
Last Update Posted: October 17, 2013
Last Verified: August 2013

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action