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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00243347
First received: October 21, 2005
Last updated: March 10, 2011
Last verified: March 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Enrollment: 24
Study Start Date: December 2005
Study Completion Date: July 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD2171
    oral tablet
    Other Names:
    • cediranib
    • RECENTIN™
  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

No publications provided

Responsible Party: Jane Robertson, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00243347     History of Changes
Other Study ID Numbers: D8480C00015
Study First Received: October 21, 2005
Last Updated: March 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
RECENTIN

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Lung 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

ClinicalTrials.gov processed this record on June 17, 2013