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Trial record 1 of 1 for:    D4200C00055
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E3-Hormone Refractory Prostrate Cancer Taxotere Combination

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ClinicalTrials.gov Identifier: NCT00498797
Recruitment Status : Completed
First Posted : July 10, 2007
Results First Posted : May 24, 2011
Last Update Posted : October 7, 2016
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Conditions Prostate Cancer
Metastatic
Hormone Refractory
Interventions Drug: Zactima (vandetanib)
Drug: Docetaxel
Drug: Prednisolone
Enrollment 86
Recruitment Details First patient randomised 24 January 2006, last patient randomised 24 Nov 2006, data cut off data 21 July 2007
Pre-assignment Details  
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description docetaxel/prednisolone/vandetanib docetaxel/prednisolone/placebo
Period Title: Overall Study
Started 43 [1] 43 [1]
Completed 5 [2] 14 [2]
Not Completed 38 29
Reason Not Completed
Withdrawal by Subject             4             2
Adverse Event             12             5
Condition under investigation worsened             19             21
Other             3             1
[1]
randomised patients
[2]
ongoing study treatment at data cut-off
Arm/Group Title Vandetanib Placebo Total
Hide Arm/Group Description docetaxel/prednisolone/vandetanib docetaxel/prednisolone/placebo Total of all reporting groups
Overall Number of Baseline Participants 43 43 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants 43 participants 86 participants
67
(47 to 81)
67
(43 to 79)
67
(43 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
43
 100.0%
43
 100.0%
86
 100.0%
1.Primary Outcome
Title Prostate Specific Antigen (PSA) Response
Hide Description Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response
Time Frame PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
docetaxel/prednisolone/vandetanib
docetaxel/prednisolone/placebo
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: Participants
17 29
2.Secondary Outcome
Title Number of Patients With an Objective Disease Progression Event
Hide Description Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Time Frame RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
docetaxel/prednisolone/vandetanib
docetaxel/prednisolone/placebo
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: Participants
28 26
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description docetaxel/prednisolone/vandetanib docetaxel/prednisolone/placebo
All-Cause Mortality
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   23/43 (53.49%)   15/43 (34.88%) 
Blood and lymphatic system disorders     
FEBRILE NEUTROPENIA  1  2/43 (4.65%)  1/43 (2.33%) 
ANAEMIA  1  0/43 (0.00%)  1/43 (2.33%) 
NEUTROPENIA  1  1/43 (2.33%)  0/43 (0.00%) 
Cardiac disorders     
ATRIAL FIBRILLATION  1  1/43 (2.33%)  1/43 (2.33%) 
Eye disorders     
BLINDNESS  1  1/43 (2.33%)  0/43 (0.00%) 
Gastrointestinal disorders     
CONSTIPATION  1  0/43 (0.00%)  1/43 (2.33%) 
DIARRHOEA  1  0/43 (0.00%)  1/43 (2.33%) 
DUODENAL ULCER HAEMORRHAGE  1  0/43 (0.00%)  1/43 (2.33%) 
GASTRIC ULCER  1  1/43 (2.33%)  0/43 (0.00%) 
LARGE INTESTINE PERFORATION  1  1/43 (2.33%)  0/43 (0.00%) 
NAUSEA  1  0/43 (0.00%)  1/43 (2.33%) 
VOMITING  1  1/43 (2.33%)  1/43 (2.33%) 
General disorders     
FATIGUE  1  0/43 (0.00%)  1/43 (2.33%) 
PYREXIA  1  0/43 (0.00%)  1/43 (2.33%) 
Hepatobiliary disorders     
CHOLELITHIASIS  1  1/43 (2.33%)  0/43 (0.00%) 
Infections and infestations     
PNEUMONIA  1  3/43 (6.98%)  1/43 (2.33%) 
DIVERTICULITIS  1  1/43 (2.33%)  0/43 (0.00%) 
LOBAR PNEUMONIA  1  1/43 (2.33%)  0/43 (0.00%) 
PERIRECTAL ABSCESS  1  1/43 (2.33%)  0/43 (0.00%) 
SEPSIS  1  1/43 (2.33%)  0/43 (0.00%) 
URINARY TRACT INFECTION  1  0/43 (0.00%)  1/43 (2.33%) 
Injury, poisoning and procedural complications     
STERNAL FRACTURE  1  0/43 (0.00%)  1/43 (2.33%) 
Metabolism and nutrition disorders     
DIABETES MELLITUS INADEQUATE CONTROL  1  1/43 (2.33%)  0/43 (0.00%) 
HYPERGLYCAEMIA  1  1/43 (2.33%)  1/43 (2.33%) 
HYPONATRAEMIA  1  1/43 (2.33%)  0/43 (0.00%) 
Musculoskeletal and connective tissue disorders     
BONE PAIN  1  1/43 (2.33%)  0/43 (0.00%) 
BURSITIS  1  1/43 (2.33%)  0/43 (0.00%) 
Nervous system disorders     
EPILEPSY  1  1/43 (2.33%)  0/43 (0.00%) 
PERIPHERAL SENSORY NEUROPATHY  1  0/43 (0.00%)  1/43 (2.33%) 
Renal and urinary disorders     
HYDRONEPHROSIS  1  0/43 (0.00%)  1/43 (2.33%) 
RENAL FAILURE  1  1/43 (2.33%)  1/43 (2.33%) 
Respiratory, thoracic and mediastinal disorders     
PULMONARY EMBOLISM  1  2/43 (4.65%)  1/43 (2.33%) 
BRONCHOSPASM  1  0/43 (0.00%)  1/43 (2.33%) 
DYSPNOEA  1  0/43 (0.00%)  1/43 (2.33%) 
Skin and subcutaneous tissue disorders     
EXFOLIATIVE RASH  1  1/43 (2.33%)  0/43 (0.00%) 
RASH ERYTHEMATOUS  1  1/43 (2.33%)  0/43 (0.00%) 
TOXIC SKIN ERUPTION  1  1/43 (2.33%)  0/43 (0.00%) 
Vascular disorders     
DEEP VEIN THROMBOSIS  1  0/43 (0.00%)  1/43 (2.33%) 
THROMBOPHLEBITIS  1  1/43 (2.33%)  0/43 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   38/43 (88.37%)   39/43 (90.70%) 
Blood and lymphatic system disorders     
ANAEMIA  1  1/43 (2.33%)  5/43 (11.63%) 
NEUTROPENIA  1  3/43 (6.98%)  4/43 (9.30%) 
LEUKOPENIA  1  1/43 (2.33%)  3/43 (6.98%) 
Cardiac disorders     
PALPITATIONS  1  3/43 (6.98%)  0/43 (0.00%) 
Ear and labyrinth disorders     
VERTIGO  1  3/43 (6.98%)  1/43 (2.33%) 
Eye disorders     
LACRIMATION INCREASED  1  4/43 (9.30%)  7/43 (16.28%) 
CONJUNCTIVITIS  1  1/43 (2.33%)  3/43 (6.98%) 
Gastrointestinal disorders     
NAUSEA  1  7/43 (16.28%)  16/43 (37.21%) 
DIARRHOEA  1  10/43 (23.26%)  13/43 (30.23%) 
CONSTIPATION  1  4/43 (9.30%)  10/43 (23.26%) 
VOMITING  1  1/43 (2.33%)  7/43 (16.28%) 
STOMATITIS  1  4/43 (9.30%)  4/43 (9.30%) 
ABDOMINAL PAIN  1  1/43 (2.33%)  3/43 (6.98%) 
DYSPEPSIA  1  3/43 (6.98%)  3/43 (6.98%) 
General disorders     
FATIGUE  1  16/43 (37.21%)  14/43 (32.56%) 
ASTHENIA  1  5/43 (11.63%)  7/43 (16.28%) 
OEDEMA PERIPHERAL  1  4/43 (9.30%)  7/43 (16.28%) 
PYREXIA  1  1/43 (2.33%)  4/43 (9.30%) 
CHILLS  1  3/43 (6.98%)  1/43 (2.33%) 
Infections and infestations     
NASOPHARYNGITIS  1  4/43 (9.30%)  6/43 (13.95%) 
URINARY TRACT INFECTION  1  5/43 (11.63%)  3/43 (6.98%) 
BRONCHITIS  1  0/43 (0.00%)  3/43 (6.98%) 
Metabolism and nutrition disorders     
ANOREXIA  1  4/43 (9.30%)  3/43 (6.98%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  5/43 (11.63%)  6/43 (13.95%) 
ARTHRALGIA  1  1/43 (2.33%)  5/43 (11.63%) 
MUSCLE SPASMS  1  3/43 (6.98%)  4/43 (9.30%) 
Nervous system disorders     
DYSGEUSIA  1  8/43 (18.60%)  5/43 (11.63%) 
HEADACHE  1  1/43 (2.33%)  5/43 (11.63%) 
DIZZINESS  1  3/43 (6.98%)  3/43 (6.98%) 
HYPOAESTHESIA  1  0/43 (0.00%)  3/43 (6.98%) 
PARAESTHESIA  1  1/43 (2.33%)  3/43 (6.98%) 
PERIPHERAL SENSORY NEUROPATHY  1  3/43 (6.98%)  2/43 (4.65%) 
Psychiatric disorders     
INSOMNIA  1  8/43 (18.60%)  7/43 (16.28%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  1/43 (2.33%)  6/43 (13.95%) 
COUGH  1  4/43 (9.30%)  4/43 (9.30%) 
EPISTAXIS  1  4/43 (9.30%)  1/43 (2.33%) 
DYSPHONIA  1  3/43 (6.98%)  1/43 (2.33%) 
PHARYNGOLARYNGEAL PAIN  1  1/43 (2.33%)  3/43 (6.98%) 
Skin and subcutaneous tissue disorders     
ALOPECIA  1  16/43 (37.21%)  19/43 (44.19%) 
RASH ERYTHEMATOUS  1  5/43 (11.63%)  1/43 (2.33%) 
ERYTHEMA  1  4/43 (9.30%)  1/43 (2.33%) 
EXFOLIATIVE RASH  1  4/43 (9.30%)  1/43 (2.33%) 
ONYCHOMADESIS  1  3/43 (6.98%)  1/43 (2.33%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  3/43 (6.98%)  2/43 (4.65%) 
PHOTOSENSITIVITY REACTION  1  3/43 (6.98%)  0/43 (0.00%) 
RASH PAPULAR  1  3/43 (6.98%)  1/43 (2.33%) 
Vascular disorders     
HYPERTENSION  1  6/43 (13.95%)  1/43 (2.33%) 
FLUSHING  1  3/43 (6.98%)  1/43 (2.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00498797     History of Changes
Other Study ID Numbers: D4200C00055
2005-003593-16 ( EudraCT Number )
First Submitted: July 9, 2007
First Posted: July 10, 2007
Results First Submitted: April 27, 2011
Results First Posted: May 24, 2011
Last Update Posted: October 7, 2016