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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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00243347
First received: October 21, 2005
Last updated: August 9, 2013
Last verified: August 2013
Results First Received: March 22, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Carcinoma
Non-Small-Cell Lung Carcinoma
Head and Neck Neoplasms
Intervention: Drug: AZD2171

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cediranib 30 mg Cediranib 30mg/Day

Participant Flow:   Overall Study
    Cediranib 30 mg  
STARTED     19 [1]
COMPLETED     0 [2]
NOT COMPLETED     19  
Lack of Efficacy                 4  
Adverse Event                 2  
Death                 1  
Withdrawal by Subject                 5  
Condition worsened                 7  
[1] Treated
[2] Completed study



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Cediranib 30 mg Cediranib 30mg/Day

Baseline Measures
    Cediranib 30 mg  
Number of Participants  
[units: participants]
  19  
Age  
[units: Years]
Mean ± Standard Deviation
  58.1  ± 12.32  
Gender  
[units: Participants]
 
Female     4  
Male     15  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Change From Baseline in Mean Arterial Blood Pressure (MAP)   [ Time Frame: Randomisation until Day 22 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Cediranib 30 mg Cediranib 30mg/Day

Other Adverse Events
    Cediranib 30 mg  
Total, other (not including serious) adverse events    
# participants affected / at risk     18/19  
Blood and lymphatic system disorders    
Lymphopenia † 1  
# participants affected / at risk     1/19 (5.26%)  
Cardiac disorders    
Pericardial Effusion † 1  
# participants affected / at risk     1/19 (5.26%)  
Endocrine disorders    
Hyperthyroidism † 1  
# participants affected / at risk     1/19 (5.26%)  
Gastrointestinal disorders    
Diarrhoea † 1  
# participants affected / at risk     8/19 (42.11%)  
Enteritis † 1  
# participants affected / at risk     3/19 (15.79%)  
Nausea † 1  
# participants affected / at risk     3/19 (15.79%)  
Vomiting † 1  
# participants affected / at risk     3/19 (15.79%)  
Stomatitis † 1  
# participants affected / at risk     2/19 (10.53%)  
Abdominal Distension † 1  
# participants affected / at risk     1/19 (5.26%)  
Abdominal Pain † 1  
# participants affected / at risk     1/19 (5.26%)  
Dry Mouth † 1  
# participants affected / at risk     1/19 (5.26%)  
Dyspepsia † 1  
# participants affected / at risk     1/19 (5.26%)  
Dysphagia † 1  
# participants affected / at risk     1/19 (5.26%)  
Gingival Bleeding † 1  
# participants affected / at risk     1/19 (5.26%)  
Oral Pain † 1  
# participants affected / at risk     1/19 (5.26%)  
General disorders    
Fatigue † 1  
# participants affected / at risk     6/19 (31.58%)  
Asthenia † 1  
# participants affected / at risk     4/19 (21.05%)  
Chest Discomfort † 1  
# participants affected / at risk     1/19 (5.26%)  
Chest Pain † 1  
# participants affected / at risk     1/19 (5.26%)  
Localised Oedema † 1  
# participants affected / at risk     1/19 (5.26%)  
Oedema Peripheral † 1  
# participants affected / at risk     1/19 (5.26%)  
Pyrexia † 1  
# participants affected / at risk     1/19 (5.26%)  
Infections and infestations    
Oral Candidiasis † 1  
# participants affected / at risk     1/19 (5.26%)  
Pneumonia † 1  
# participants affected / at risk     1/19 (5.26%)  
Injury, poisoning and procedural complications    
Limb Injury † 1  
# participants affected / at risk     1/19 (5.26%)  
Blood Corticotrophin Increased † 1  
# participants affected / at risk     4/19 (21.05%)  
Weight Decreased † 1  
# participants affected / at risk     4/19 (21.05%)  
Blood Thyroid Stimulating Hormone Increased † 1  
# participants affected / at risk     2/19 (10.53%)  
Blood Thyroid Stimulating Hormone Decreased † 1  
# participants affected / at risk     1/19 (5.26%)  
Haemoglobin Decreased † 1  
# participants affected / at risk     1/19 (5.26%)  
Urine Colour Abnormal † 1  
# participants affected / at risk     1/19 (5.26%)  
White Blood Cell Count Decreased † 1  
# participants affected / at risk     1/19 (5.26%)  
Metabolism and nutrition disorders    
Anorexia † 1  
# participants affected / at risk     3/19 (15.79%)  
Dehydration † 1  
# participants affected / at risk     3/19 (15.79%)  
Hyperglycaemia † 1  
# participants affected / at risk     2/19 (10.53%)  
Hypercholesterolaemia † 1  
# participants affected / at risk     1/19 (5.26%)  
Hypertriglyceridaemia † 1  
# participants affected / at risk     1/19 (5.26%)  
Hyperuricaemia † 1  
# participants affected / at risk     1/19 (5.26%)  
Hypokalaemia † 1  
# participants affected / at risk     1/19 (5.26%)  
Hypomagnesaemia † 1  
# participants affected / at risk     1/19 (5.26%)  
Musculoskeletal and connective tissue disorders    
Neck Pain † 1  
# participants affected / at risk     3/19 (15.79%)  
Muscle Spasms † 1  
# participants affected / at risk     2/19 (10.53%)  
Arthralgia † 1  
# participants affected / at risk     1/19 (5.26%)  
Back Pain † 1  
# participants affected / at risk     1/19 (5.26%)  
Myalgia † 1  
# participants affected / at risk     1/19 (5.26%)  
Nervous system disorders    
Aphonia † 1  
# participants affected / at risk     1/19 (5.26%)  
Cervical Root Pain † 1  
# participants affected / at risk     1/19 (5.26%)  
Dysarthria † 1  
# participants affected / at risk     1/19 (5.26%)  
Headache † 1  
# participants affected / at risk     1/19 (5.26%)  
Hypoaesthesia † 1  
# participants affected / at risk     1/19 (5.26%)  
Migraine † 1  
# participants affected / at risk     1/19 (5.26%)  
Neuropathy Peripheral † 1  
# participants affected / at risk     1/19 (5.26%)  
Peripheral Sensory Neuropathy † 1  
# participants affected / at risk     1/19 (5.26%)  
Psychiatric disorders    
Depression † 1  
# participants affected / at risk     1/19 (5.26%)  
Insomnia † 1  
# participants affected / at risk     1/19 (5.26%)  
Renal and urinary disorders    
Proteinuria † 1  
# participants affected / at risk     8/19 (42.11%)  
Ketonuria † 1  
# participants affected / at risk     1/19 (5.26%)  
Renal Failure † 1  
# participants affected / at risk     1/19 (5.26%)  
Reproductive system and breast disorders    
Menorrhagia † 1  
# participants affected / at risk     1/19 (5.26%)  
Respiratory, thoracic and mediastinal disorders    
Rhinorrhoea † 1  
# participants affected / at risk     3/19 (15.79%)  
Dyspnoea † 1  
# participants affected / at risk     2/19 (10.53%)  
Cough † 1  
# participants affected / at risk     1/19 (5.26%)  
Epistaxis † 1  
# participants affected / at risk     1/19 (5.26%)  
Pleural Effusion † 1  
# participants affected / at risk     1/19 (5.26%)  
Skin and subcutaneous tissue disorders    
Pruritus † 1  
# participants affected / at risk     3/19 (15.79%)  
Rash † 1  
# participants affected / at risk     2/19 (10.53%)  
Dry Skin † 1  
# participants affected / at risk     1/19 (5.26%)  
Ecchymosis † 1  
# participants affected / at risk     1/19 (5.26%)  
Palmar-Plantar Erythrodysaesthesia Syndrome † 1  
# participants affected / at risk     1/19 (5.26%)  
Skin Reaction † 1  
# participants affected / at risk     1/19 (5.26%)  
Vascular disorders    
Hypertension † 1  
# participants affected / at risk     6/19 (31.58%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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