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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:
ClinicalTrials.gov Identifier:
NCT00243347
First Posted: October 24, 2005
Last Update Posted: October 17, 2013
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.
Information provided by (Responsible Party):
AstraZeneca
October 21, 2005
October 24, 2005
March 22, 2013
October 17, 2013
October 17, 2013
December 2005
May 2008   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00243347 on ClinicalTrials.gov Archive Site
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).
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The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma
  • Non-Small-Cell Lung Carcinoma
  • Head and Neck Neoplasms
Drug: AZD2171
oral tablet
Other Names:
  • cediranib
  • RECENTIN™
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
July 2009
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain,   United States
 
 
NCT00243347
D8480C00015
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AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Oncology Medical Sciences Director, MD AstraZeneca
AstraZeneca
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP