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A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer (ENTHUSE M1C)

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ClinicalTrials.gov Identifier: NCT00617669
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : May 31, 2012
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Docetaxel
Drug: ZD4054
Drug: Placebo
Enrollment 1494
Recruitment Details 1494 patients with hormone resistant prostate cancer patients and bone metastasis were recruited between 24th January 2008 and 10th May 2011
Pre-assignment Details 442 of the 1494 enrolled patients were not randomised to treatment groups as they failed screening.
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Period Title: Overall Study
Started 524 528
Patients Who Received IP 522 525
Completed 94 [1] 77 [2]
Not Completed 430 451
Reason Not Completed
Withdrawal by Subject             71             77
Lost to Follow-up             3             2
Adverse Event             87             76
Protocol Violation             2             3
Reason not otherwise captured, eg; death             265             290
Patients randomized but not treated             2             3
[1]
Patients receiving ZD4054 10 mg at data cut-off
[2]
Patients receiving placebo at data cut-off
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel Total
Hide Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks Total of all reporting groups
Overall Number of Baseline Participants 524 528 1052
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
overall Number Analyzed 524 participants 528 participants 1052 participants
8.1  (67.7) 7.8  (67.6) 7.9  (67.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 524 participants 528 participants 1052 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
524
 100.0%
528
 100.0%
1052
 100.0%
1.Primary Outcome
Title Overall Survival
Hide Description Median time (in months) from randomisation until death using the Kaplan-Meier method.
Time Frame Patients were followed for survival up to 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description:
XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Overall Number of Participants Analyzed 524 528
Median (Inter-Quartile Range)
Unit of Measure: Months
20.0
(11.6 to 32.0)
19.2
(12.0 to 30.3)
2.Secondary Outcome
Title Progression Free Survival
Hide Description Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
Time Frame Patients were followed for progression up to 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description:
XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Overall Number of Participants Analyzed 524 528
Median (Inter-Quartile Range)
Unit of Measure: Months
7.0
(3.5 to 13.1)
7.9
(4.0 to 12.6)
3.Secondary Outcome
Title Incidence of Skeletal Related Events
Hide Description Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.
Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description:
XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Overall Number of Participants Analyzed 524 528
Median (Inter-Quartile Range)
Unit of Measure: Months
17.4
(10.0 to 25.3)
17.3
(10.3 to 26.0)
4.Secondary Outcome
Title Time to Prostate-specific Antigen (PSA) Progression
Hide Description Median time (in months) from randomisation until first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.
Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description:
XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Overall Number of Participants Analyzed 524 528
Median (Inter-Quartile Range)
Unit of Measure: Months
11.9
(6.2 to 19.6)
12.1
(6.0 to 18.3)
5.Secondary Outcome
Title Time to Pain Progression
Hide Description Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.
Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description:
XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Overall Number of Participants Analyzed 524 528
Median (Inter-Quartile Range)
Unit of Measure: Months
9.3
(3.9 to 18.4)
10.0
(4.2 to 18.6)
6.Secondary Outcome
Title Pain Response
Hide Description Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.
Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2.
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description:
XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Overall Number of Participants Analyzed 362 373
Measure Type: Number
Unit of Measure: Participants
255 276
7.Secondary Outcome
Title Health Related Quality of Life
Hide Description Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.
Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description:
XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Overall Number of Participants Analyzed 524 528
Median (Inter-Quartile Range)
Unit of Measure: Months
4.4
(1.6 to 10.7)
5.1
(2.1 to 12.0)
8.Secondary Outcome
Title PSA Response
Hide Description PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.
Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description:
XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Overall Number of Participants Analyzed 524 528
Measure Type: Number
Unit of Measure: Participants
279 298
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
Hide Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
All-Cause Mortality
ZD4054 + Docetaxel Placebo + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
ZD4054 + Docetaxel Placebo + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   214/522 (41.00%)   203/525 (38.67%) 
Blood and lymphatic system disorders     
Febrile Neutropenia † 1  22/522 (4.21%)  16/525 (3.05%) 
Anaemia † 1  19/522 (3.64%)  8/525 (1.52%) 
Neutropenia † 1  10/522 (1.92%)  12/525 (2.29%) 
Leukopenia † 1  2/522 (0.38%)  4/525 (0.76%) 
Coagulopathy † 1  0/522 (0.00%)  1/525 (0.19%) 
Lymphatic Obstruction † 1  1/522 (0.19%)  0/525 (0.00%) 
Cardiac disorders     
Atrial Fibrillation † 1  5/522 (0.96%)  2/525 (0.38%) 
Cardiac Failure † 1  5/522 (0.96%)  2/525 (0.38%) 
Acute Myocardial Infarction † 1  3/522 (0.57%)  4/525 (0.76%) 
Angina Pectoris † 1  2/522 (0.38%)  2/525 (0.38%) 
Atrial Flutter † 1  1/522 (0.19%)  2/525 (0.38%) 
Cardiac Failure Congestive † 1  2/522 (0.38%)  0/525 (0.00%) 
Cardio-Respiratory Arrest † 1  0/522 (0.00%)  2/525 (0.38%) 
Coronary Artery Stenosis † 1  2/522 (0.38%)  0/525 (0.00%) 
Myocardial Infarction † 1  2/522 (0.38%)  2/525 (0.38%) 
Myocardial Ischaemia † 1  0/522 (0.00%)  2/525 (0.38%) 
Ventricular Tachycardia † 1  0/522 (0.00%)  2/525 (0.38%) 
Angina Unstable † 1  0/522 (0.00%)  1/525 (0.19%) 
Aortic Valve Disease † 1  1/522 (0.19%)  0/525 (0.00%) 
Arrhythmia † 1  0/522 (0.00%)  1/525 (0.19%) 
Bradycardia † 1  1/522 (0.19%)  0/525 (0.00%) 
Cardiac Arrest † 1  1/522 (0.19%)  1/525 (0.19%) 
Cardiopulmonary Failure † 1  1/522 (0.19%)  0/525 (0.00%) 
Coronary Artery Disease † 1  0/522 (0.00%)  1/525 (0.19%) 
Diastolic Dysfunction † 1  0/522 (0.00%)  1/525 (0.19%) 
Hypertrophic Cardiomyopathy † 1  1/522 (0.19%)  0/525 (0.00%) 
Left Ventricular Dysfunction † 1  1/522 (0.19%)  0/525 (0.00%) 
Sinus Tachycardia † 1  1/522 (0.19%)  0/525 (0.00%) 
Endocrine disorders     
Adrenal Insufficiency † 1  1/522 (0.19%)  0/525 (0.00%) 
Adrenocortical Insufficiency Acute † 1  0/522 (0.00%)  1/525 (0.19%) 
Inappropriate Antidiuretic Hormone Secretion † 1  0/522 (0.00%)  1/525 (0.19%) 
Eye disorders     
Cataract † 1  0/522 (0.00%)  1/525 (0.19%) 
Scleral Disorder † 1  1/522 (0.19%)  0/525 (0.00%) 
Staphyloma † 1  0/522 (0.00%)  1/525 (0.19%) 
Visual Acuity Reduced † 1  1/522 (0.19%)  0/525 (0.00%) 
Gastrointestinal disorders     
Diarrhoea † 1  6/522 (1.15%)  5/525 (0.95%) 
Constipation † 1  3/522 (0.57%)  3/525 (0.57%) 
Ileus † 1  0/522 (0.00%)  3/525 (0.57%) 
Abdominal Pain † 1  2/522 (0.38%)  0/525 (0.00%) 
Enterocolitis † 1  2/522 (0.38%)  0/525 (0.00%) 
Gastric Ulcer † 1  1/522 (0.19%)  2/525 (0.38%) 
Haemorrhoids † 1  1/522 (0.19%)  2/525 (0.38%) 
Nausea † 1  2/522 (0.38%)  0/525 (0.00%) 
Upper Gastrointestinal Haemorrhage † 1  2/522 (0.38%)  0/525 (0.00%) 
Vomiting † 1  2/522 (0.38%)  1/525 (0.19%) 
Anal Fistula † 1  0/522 (0.00%)  1/525 (0.19%) 
Ascites † 1  0/522 (0.00%)  1/525 (0.19%) 
Colitis † 1  0/522 (0.00%)  1/525 (0.19%) 
Colitis Ischaemic † 1  1/522 (0.19%)  0/525 (0.00%) 
Colonic Polyp † 1  1/522 (0.19%)  0/525 (0.00%) 
Diarrhoea Haemorrhagic † 1  0/522 (0.00%)  1/525 (0.19%) 
Diverticulum † 1  0/522 (0.00%)  1/525 (0.19%) 
Duodenal Ulcer † 1  1/522 (0.19%)  1/525 (0.19%) 
Erosive Oesophagitis † 1  1/522 (0.19%)  0/525 (0.00%) 
Gastric Ulcer Haemorrhage † 1  1/522 (0.19%)  0/525 (0.00%) 
Gastritis † 1  1/522 (0.19%)  1/525 (0.19%) 
Gastrointestinal Haemorrhage † 1  0/522 (0.00%)  1/525 (0.19%) 
Haematemesis † 1  1/522 (0.19%)  0/525 (0.00%) 
Inguinal Hernia † 1  0/522 (0.00%)  1/525 (0.19%) 
Inguinal Hernia Strangulated † 1  0/522 (0.00%)  1/525 (0.19%) 
Intestinal Infarction † 1  1/522 (0.19%)  0/525 (0.00%) 
Irritable Bowel Syndrome † 1  1/522 (0.19%)  0/525 (0.00%) 
Large Intestinal Haemorrhage † 1  1/522 (0.19%)  0/525 (0.00%) 
Lower Gastrointestinal Haemorrhage † 1  0/522 (0.00%)  1/525 (0.19%) 
Melaena † 1  0/522 (0.00%)  1/525 (0.19%) 
Mouth Haemorrhage † 1  1/522 (0.19%)  0/525 (0.00%) 
Neutropenic Colitis † 1  0/522 (0.00%)  1/525 (0.19%) 
Oesophagitis Ulcerative † 1  1/522 (0.19%)  0/525 (0.00%) 
Rectal Haemorrhage † 1  1/522 (0.19%)  0/525 (0.00%) 
Rectourethral Fistula † 1  1/522 (0.19%)  0/525 (0.00%) 
Small Intestinal Obstruction † 1  1/522 (0.19%)  1/525 (0.19%) 
General disorders     
Pyrexia † 1  6/522 (1.15%)  12/525 (2.29%) 
Death † 1  10/522 (1.92%)  6/525 (1.14%) 
Oedema Peripheral † 1  6/522 (1.15%)  3/525 (0.57%) 
General Physical Health Deterioration † 1  0/522 (0.00%)  3/525 (0.57%) 
Asthenia † 1  0/522 (0.00%)  2/525 (0.38%) 
Disease Progression † 1  1/522 (0.19%)  2/525 (0.38%) 
Medical Device Complication † 1  0/522 (0.00%)  2/525 (0.38%) 
Chest Pain † 1  1/522 (0.19%)  0/525 (0.00%) 
Device Occlusion † 1  1/522 (0.19%)  1/525 (0.19%) 
Pain † 1  1/522 (0.19%)  0/525 (0.00%) 
Sudden Death † 1  1/522 (0.19%)  0/525 (0.00%) 
Hepatobiliary disorders     
Cholecystitis Acute † 1  0/522 (0.00%)  1/525 (0.19%) 
Hepatic Cirrhosis † 1  0/522 (0.00%)  1/525 (0.19%) 
Hypertransaminasaemia † 1  1/522 (0.19%)  0/525 (0.00%) 
Immune system disorders     
Drug Hypersensitivity † 1  2/522 (0.38%)  0/525 (0.00%) 
Hypersensitivity † 1  1/522 (0.19%)  1/525 (0.19%) 
Infections and infestations     
Pneumonia † 1  26/522 (4.98%)  8/525 (1.52%) 
Sepsis † 1  10/522 (1.92%)  2/525 (0.38%) 
Urinary Tract Infection † 1  9/522 (1.72%)  7/525 (1.33%) 
Urosepsis † 1  4/522 (0.77%)  5/525 (0.95%) 
Cellulitis † 1  4/522 (0.77%)  1/525 (0.19%) 
Neutropenic Sepsis † 1  4/522 (0.77%)  3/525 (0.57%) 
Bronchopneumonia † 1  3/522 (0.57%)  2/525 (0.38%) 
Lung Infection † 1  3/522 (0.57%)  0/525 (0.00%) 
Bronchitis † 1  2/522 (0.38%)  1/525 (0.19%) 
Cystitis † 1  2/522 (0.38%)  0/525 (0.00%) 
Gastroenteritis † 1  2/522 (0.38%)  2/525 (0.38%) 
Infection † 1  0/522 (0.00%)  2/525 (0.38%) 
Lobar Pneumonia † 1  0/522 (0.00%)  2/525 (0.38%) 
Lower Respiratory Tract Infection † 1  2/522 (0.38%)  2/525 (0.38%) 
Pharyngitis † 1  2/522 (0.38%)  0/525 (0.00%) 
Pyelonephritis † 1  2/522 (0.38%)  1/525 (0.19%) 
Sinusitis † 1  2/522 (0.38%)  0/525 (0.00%) 
Skin Infection † 1  2/522 (0.38%)  0/525 (0.00%) 
Upper Respiratory Tract Infection † 1  2/522 (0.38%)  1/525 (0.19%) 
Abscess † 1  0/522 (0.00%)  1/525 (0.19%) 
Abscess Limb † 1  0/522 (0.00%)  1/525 (0.19%) 
Anal Abscess † 1  0/522 (0.00%)  1/525 (0.19%) 
Appendicitis † 1  1/522 (0.19%)  1/525 (0.19%) 
Arthritis Bacterial † 1  0/522 (0.00%)  1/525 (0.19%) 
Arthritis Infective † 1  0/522 (0.00%)  1/525 (0.19%) 
Bacterial Diarrhoea † 1  1/522 (0.19%)  0/525 (0.00%) 
Catheter Site Infection † 1  0/522 (0.00%)  1/525 (0.19%) 
Clostridium Difficile Colitis † 1  0/522 (0.00%)  1/525 (0.19%) 
Diverticulitis † 1  0/522 (0.00%)  1/525 (0.19%) 
Endocarditis † 1  1/522 (0.19%)  0/525 (0.00%) 
Erysipelas † 1  0/522 (0.00%)  1/525 (0.19%) 
Furuncle † 1  0/522 (0.00%)  1/525 (0.19%) 
Herpes Zoster † 1  1/522 (0.19%)  0/525 (0.00%) 
Labyrinthitis † 1  1/522 (0.19%)  0/525 (0.00%) 
Localised Infection † 1  0/522 (0.00%)  1/525 (0.19%) 
Lyme Disease † 1  0/522 (0.00%)  1/525 (0.19%) 
Necrotising Fasciitis † 1  1/522 (0.19%)  0/525 (0.00%) 
Neutropenic Infection † 1  0/522 (0.00%)  1/525 (0.19%) 
Otitis Media † 1  1/522 (0.19%)  0/525 (0.00%) 
Peritonitis Bacterial † 1  1/522 (0.19%)  0/525 (0.00%) 
Pneumocystis Jiroveci Pneumonia † 1  0/522 (0.00%)  1/525 (0.19%) 
Postoperative Wound Infection † 1  0/522 (0.00%)  1/525 (0.19%) 
Psoas Abscess † 1  0/522 (0.00%)  1/525 (0.19%) 
Pulmonary Tuberculosis † 1  1/522 (0.19%)  0/525 (0.00%) 
Respiratory Tract Infection † 1  1/522 (0.19%)  1/525 (0.19%) 
Staphylococcal Bacteraemia † 1  1/522 (0.19%)  1/525 (0.19%) 
Staphylococcal Infection † 1  1/522 (0.19%)  0/525 (0.00%) 
Subcutaneous Abscess † 1  1/522 (0.19%)  0/525 (0.00%) 
Tooth Infection † 1  0/522 (0.00%)  1/525 (0.19%) 
Tracheobronchitis † 1  1/522 (0.19%)  0/525 (0.00%) 
Injury, poisoning and procedural complications     
Femoral Neck Fracture † 1  2/522 (0.38%)  1/525 (0.19%) 
Subdural Haematoma † 1  1/522 (0.19%)  2/525 (0.38%) 
Cerebral Haemorrhage Traumatic † 1  0/522 (0.00%)  1/525 (0.19%) 
Facial Bones Fracture † 1  1/522 (0.19%)  0/525 (0.00%) 
Hip Fracture † 1  1/522 (0.19%)  1/525 (0.19%) 
Kidney Rupture † 1  0/522 (0.00%)  1/525 (0.19%) 
Multiple Injuries † 1  1/522 (0.19%)  0/525 (0.00%) 
Overdose † 1  1/522 (0.19%)  0/525 (0.00%) 
Postoperative Wound Complication † 1  0/522 (0.00%)  1/525 (0.19%) 
Radiation Pneumonitis † 1  1/522 (0.19%)  0/525 (0.00%) 
Spinal Compression Fracture † 1  0/522 (0.00%)  1/525 (0.19%) 
Stress Fracture † 1  0/522 (0.00%)  1/525 (0.19%) 
Toxicity To Various Agents † 1  1/522 (0.19%)  0/525 (0.00%) 
Wrist Fracture † 1  1/522 (0.19%)  0/525 (0.00%) 
Haemoglobin Decreased † 1  2/522 (0.38%)  0/525 (0.00%) 
Blood Electrolytes Abnormal † 1  1/522 (0.19%)  0/525 (0.00%) 
Electrocardiogram QT Prolonged † 1  0/522 (0.00%)  1/525 (0.19%) 
Neutrophil Count Decreased † 1  0/522 (0.00%)  1/525 (0.19%) 
Transaminases Increased † 1  0/522 (0.00%)  1/525 (0.19%) 
Metabolism and nutrition disorders     
Dehydration † 1  7/522 (1.34%)  8/525 (1.52%) 
Hyponatraemia † 1  6/522 (1.15%)  5/525 (0.95%) 
Hyperglycaemia † 1  4/522 (0.77%)  3/525 (0.57%) 
Type 2 Diabetes Mellitus † 1  0/522 (0.00%)  4/525 (0.76%) 
Hypophosphataemia † 1  0/522 (0.00%)  2/525 (0.38%) 
Diabetes Mellitus † 1  0/522 (0.00%)  1/525 (0.19%) 
Hyperkalaemia † 1  0/522 (0.00%)  1/525 (0.19%) 
Hypernatraemia † 1  1/522 (0.19%)  0/525 (0.00%) 
Hypocalcaemia † 1  1/522 (0.19%)  1/525 (0.19%) 
Hypoglycaemia † 1  1/522 (0.19%)  1/525 (0.19%) 
Musculoskeletal and connective tissue disorders     
Osteonecrosis Of Jaw † 1  2/522 (0.38%)  2/525 (0.38%) 
Pathological Fracture † 1  1/522 (0.19%)  2/525 (0.38%) 
Arthralgia † 1  1/522 (0.19%)  0/525 (0.00%) 
Back Pain † 1  1/522 (0.19%)  1/525 (0.19%) 
Bone Pain † 1  0/522 (0.00%)  1/525 (0.19%) 
Bursitis † 1  0/522 (0.00%)  1/525 (0.19%) 
Muscular Weakness † 1  0/522 (0.00%)  1/525 (0.19%) 
Musculoskeletal Pain † 1  1/522 (0.19%)  0/525 (0.00%) 
Myalgia † 1  0/522 (0.00%)  1/525 (0.19%) 
Osteonecrosis † 1  1/522 (0.19%)  1/525 (0.19%) 
Rheumatoid Arthritis † 1  0/522 (0.00%)  1/525 (0.19%) 
Synovitis † 1  0/522 (0.00%)  1/525 (0.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant Melanoma † 1  0/522 (0.00%)  2/525 (0.38%) 
Basal Cell Carcinoma † 1  1/522 (0.19%)  0/525 (0.00%) 
Bladder Transitional Cell Carcinoma † 1  0/522 (0.00%)  1/525 (0.19%) 
Colorectal Cancer † 1  0/522 (0.00%)  1/525 (0.19%) 
Gastrointestinal Stromal Tumour † 1  0/522 (0.00%)  1/525 (0.19%) 
Lentigo Maligna Stage Unspecified † 1  1/522 (0.19%)  0/525 (0.00%) 
Malignant Lymphoid Neoplasm † 1  0/522 (0.00%)  1/525 (0.19%) 
Rectal Cancer † 1  1/522 (0.19%)  0/525 (0.00%) 
Renal Cell Carcinoma † 1  1/522 (0.19%)  0/525 (0.00%) 
Nervous system disorders     
Cerebrovascular Accident † 1  3/522 (0.57%)  1/525 (0.19%) 
Cerebral Haemorrhage † 1  0/522 (0.00%)  2/525 (0.38%) 
Cerebral Infarction † 1  1/522 (0.19%)  2/525 (0.38%) 
Presyncope † 1  1/522 (0.19%)  2/525 (0.38%) 
Transient Ischaemic Attack † 1  0/522 (0.00%)  2/525 (0.38%) 
Convulsion † 1  0/522 (0.00%)  1/525 (0.19%) 
Depressed Level Of Consciousness † 1  1/522 (0.19%)  0/525 (0.00%) 
Diabetic Neuropathy † 1  1/522 (0.19%)  0/525 (0.00%) 
Dizziness † 1  1/522 (0.19%)  0/525 (0.00%) 
Encephalopathy † 1  1/522 (0.19%)  0/525 (0.00%) 
Ischaemic Stroke † 1  1/522 (0.19%)  1/525 (0.19%) 
Neurotoxicity † 1  1/522 (0.19%)  0/525 (0.00%) 
Paraplegia † 1  1/522 (0.19%)  0/525 (0.00%) 
Radiculopathy † 1  1/522 (0.19%)  0/525 (0.00%) 
Spinal Cord Compression † 1  1/522 (0.19%)  1/525 (0.19%) 
Subarachnoid Haemorrhage † 1  1/522 (0.19%)  1/525 (0.19%) 
Syncope † 1  1/522 (0.19%)  1/525 (0.19%) 
Psychiatric disorders     
Completed Suicide † 1  1/522 (0.19%)  3/525 (0.57%) 
Confusional State † 1  1/522 (0.19%)  0/525 (0.00%) 
Delirium † 1  0/522 (0.00%)  1/525 (0.19%) 
Depression † 1  0/522 (0.00%)  1/525 (0.19%) 
Renal and urinary disorders     
Renal Failure Acute † 1  7/522 (1.34%)  2/525 (0.38%) 
Haematuria † 1  2/522 (0.38%)  4/525 (0.76%) 
Urinary Retention † 1  1/522 (0.19%)  2/525 (0.38%) 
Bladder Neck Obstruction † 1  1/522 (0.19%)  0/525 (0.00%) 
Bladder Obstruction † 1  1/522 (0.19%)  0/525 (0.00%) 
Calculus Ureteric † 1  0/522 (0.00%)  1/525 (0.19%) 
Calculus Urinary † 1  0/522 (0.00%)  1/525 (0.19%) 
Cystitis Noninfective † 1  0/522 (0.00%)  1/525 (0.19%) 
Haemorrhage Urinary Tract † 1  1/522 (0.19%)  0/525 (0.00%) 
Postrenal Failure † 1  1/522 (0.19%)  0/525 (0.00%) 
Renal Colic † 1  1/522 (0.19%)  0/525 (0.00%) 
Renal Failure † 1  1/522 (0.19%)  0/525 (0.00%) 
Renal Tubular Necrosis † 1  1/522 (0.19%)  0/525 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism † 1  6/522 (1.15%)  7/525 (1.33%) 
Dyspnoea † 1  0/522 (0.00%)  5/525 (0.95%) 
Pleural Effusion † 1  3/522 (0.57%)  4/525 (0.76%) 
Respiratory Failure † 1  4/522 (0.77%)  2/525 (0.38%) 
Lung Disorder † 1  2/522 (0.38%)  0/525 (0.00%) 
Respiratory Distress † 1  2/522 (0.38%)  1/525 (0.19%) 
Acute Respiratory Distress Syndrome † 1  1/522 (0.19%)  0/525 (0.00%) 
Acute Respiratory Failure † 1  1/522 (0.19%)  0/525 (0.00%) 
Bronchitis Chronic † 1  0/522 (0.00%)  1/525 (0.19%) 
Cough † 1  1/522 (0.19%)  1/525 (0.19%) 
Emphysema † 1  1/522 (0.19%)  0/525 (0.00%) 
Haemoptysis † 1  0/522 (0.00%)  1/525 (0.19%) 
Interstitial Lung Disease † 1  0/522 (0.00%)  1/525 (0.19%) 
Orthopnoea † 1  0/522 (0.00%)  1/525 (0.19%) 
Pleural Haemorrhage † 1  0/522 (0.00%)  1/525 (0.19%) 
Pneumonitis † 1  1/522 (0.19%)  1/525 (0.19%) 
Skin and subcutaneous tissue disorders     
Erythema † 1  0/522 (0.00%)  1/525 (0.19%) 
Skin Ulcer † 1  1/522 (0.19%)  0/525 (0.00%) 
Stevens-Johnson Syndrome † 1  0/522 (0.00%)  1/525 (0.19%) 
Vascular disorders     
Deep Vein Thrombosis † 1  3/522 (0.57%)  2/525 (0.38%) 
Aortic Aneurysm † 1  2/522 (0.38%)  0/525 (0.00%) 
Hypotension † 1  2/522 (0.38%)  2/525 (0.38%) 
Jugular Vein Thrombosis † 1  0/522 (0.00%)  2/525 (0.38%) 
Circulatory Collapse † 1  0/522 (0.00%)  1/525 (0.19%) 
Femoral Artery Occlusion † 1  0/522 (0.00%)  1/525 (0.19%) 
Haematoma † 1  0/522 (0.00%)  1/525 (0.19%) 
Hypertension † 1  1/522 (0.19%)  0/525 (0.00%) 
Hypovolaemic Shock † 1  1/522 (0.19%)  1/525 (0.19%) 
Shock † 1  1/522 (0.19%)  0/525 (0.00%) 
sThrombosis † 1  0/522 (0.00%)  1/525 (0.19%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZD4054 + Docetaxel Placebo + Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   490/522 (93.87%)   483/525 (92.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  155/522 (29.69%)  116/525 (22.10%) 
Neutropenia † 2  114/522 (21.84%)  118/525 (22.48%) 
Leukopenia † 2  64/522 (12.26%)  60/525 (11.43%) 
Eye disorders     
Lacrimation Increased † 2  38/522 (7.28%)  36/525 (6.86%) 
Gastrointestinal disorders     
Diarrhoea † 2  183/522 (35.06%)  185/525 (35.24%) 
Nausea † 2  174/522 (33.33%)  160/525 (30.48%) 
Constipation † 2  152/522 (29.12%)  129/525 (24.57%) 
Vomiting † 2  110/522 (21.07%)  84/525 (16.00%) 
Dyspepsia † 2  21/522 (4.02%)  40/525 (7.62%) 
Stomatitis † 2  32/522 (6.13%)  35/525 (6.67%) 
Abdominal Pain † 2  25/522 (4.79%)  34/525 (6.48%) 
Abdominal Pain Upper † 2  31/522 (5.94%)  27/525 (5.14%) 
General disorders     
Oedema Peripheral † 2  278/522 (53.26%)  188/525 (35.81%) 
Fatigue † 2  150/522 (28.74%)  164/525 (31.24%) 
Asthenia † 2  118/522 (22.61%)  117/525 (22.29%) 
Pyrexia † 2  59/522 (11.30%)  60/525 (11.43%) 
Mucosal Inflammation † 2  37/522 (7.09%)  28/525 (5.33%) 
Infections and infestations     
Rhinitis † 2  51/522 (9.77%)  36/525 (6.86%) 
Urinary Tract Infection † 2  37/522 (7.09%)  48/525 (9.14%) 
Nasopharyngitis † 2  30/522 (5.75%)  36/525 (6.86%) 
Upper Respiratory Tract Infection † 2  18/522 (3.45%)  27/525 (5.14%) 
Weight Decreased † 2  37/522 (7.09%)  37/525 (7.05%) 
Metabolism and nutrition disorders     
Decreased Appetite † 2  127/522 (24.33%)  119/525 (22.67%) 
Hypocalcaemia † 2  29/522 (5.56%)  17/525 (3.24%) 
Hypokalaemia † 2  25/522 (4.79%)  27/525 (5.14%) 
Musculoskeletal and connective tissue disorders     
Back Pain † 2  94/522 (18.01%)  91/525 (17.33%) 
Arthralgia † 2  80/522 (15.33%)  86/525 (16.38%) 
Pain In Extremity † 2  71/522 (13.60%)  84/525 (16.00%) 
Myalgia † 2  42/522 (8.05%)  53/525 (10.10%) 
Musculoskeletal Pain † 2  46/522 (8.81%)  28/525 (5.33%) 
Muscle Spasms † 2  22/522 (4.21%)  37/525 (7.05%) 
Muscular Weakness † 2  29/522 (5.56%)  37/525 (7.05%) 
Bone Pain † 2  28/522 (5.36%)  32/525 (6.10%) 
Musculoskeletal Chest Pain † 2  32/522 (6.13%)  20/525 (3.81%) 
Nervous system disorders     
Headache † 2  107/522 (20.50%)  71/525 (13.52%) 
Dysgeusia † 2  88/522 (16.86%)  73/525 (13.90%) 
Neuropathy Peripheral † 2  49/522 (9.39%)  65/525 (12.38%) 
Paraesthesia † 2  45/522 (8.62%)  48/525 (9.14%) 
Dizziness † 2  43/522 (8.24%)  45/525 (8.57%) 
Peripheral Sensory Neuropathy † 2  41/522 (7.85%)  39/525 (7.43%) 
Hypoaesthesia † 2  24/522 (4.60%)  28/525 (5.33%) 
Psychiatric disorders     
Insomnia † 2  71/522 (13.60%)  59/525 (11.24%) 
Renal and urinary disorders     
Haematuria † 2  30/522 (5.75%)  17/525 (3.24%) 
Dysuria † 2  29/522 (5.56%)  19/525 (3.62%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 2  82/522 (15.71%)  72/525 (13.71%) 
Cough † 2  58/522 (11.11%)  78/525 (14.86%) 
Nasal Congestion † 2  78/522 (14.94%)  26/525 (4.95%) 
Dyspnoea Exertional † 2  43/522 (8.24%)  38/525 (7.24%) 
Epistaxis † 2  26/522 (4.98%)  31/525 (5.90%) 
Skin and subcutaneous tissue disorders     
Alopecia † 2  178/522 (34.10%)  196/525 (37.33%) 
Rash † 2  24/522 (4.60%)  40/525 (7.62%) 
Nail Discolouration † 2  28/522 (5.36%)  39/525 (7.43%) 
Dry Skin † 2  32/522 (6.13%)  28/525 (5.33%) 
Nail Disorder † 2  23/522 (4.41%)  28/525 (5.33%) 
Vascular disorders     
Hypertension † 2  16/522 (3.07%)  37/525 (7.05%) 
Hypotension † 2  33/522 (6.32%)  28/525 (5.33%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
2
Term from vocabulary, MedDRA 10.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

3. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

AstraZeneca can review results communications prior to public release and may within 60 days of receipt require amendments to be made. AstraZeneca can also require that submission or disclosure be delayed to allow for

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00617669    
Other Study ID Numbers: D4320C00033
First Submitted: January 24, 2008
First Posted: February 18, 2008
Results First Submitted: April 26, 2012
Results First Posted: May 31, 2012
Last Update Posted: September 10, 2012