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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00243347
First received: October 21, 2005
Last updated: August 9, 2013
Last verified: August 2013
  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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Mean Arterial Blood Pressure (MAP) [ Time Frame: Randomisation until Day 22 ] [ Designated as safety issue: No ]
    Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).


Enrollment: 19
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
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, see Learn About Clinical Studies.

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: AstraZeneca
ClinicalTrials.gov Identifier: NCT00243347     History of Changes
Other Study ID Numbers: D8480C00015
Study First Received: October 21, 2005
Results First Received: March 22, 2013
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
RECENTIN

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

ClinicalTrials.gov processed this record on October 19, 2014