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Trial record 1 of 1 for:    D4200C00046
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E3 Breast Cancer Taxotere Combination

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ClinicalTrials.gov Identifier: NCT00494481
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : May 24, 2011
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Advanced Breast Cancer
Interventions Drug: Vandetanib (ZD6474)
Drug: Docetaxel
Enrollment 64
Recruitment Details First patient randomised 03 February 2006, last patient randomised 25 April 2007, data cut off data 23 June 2007
Pre-assignment Details  
Arm/Group Title Vandetanib Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description vandetanib 100 mg plus docetaxel placebo plus docetaxel
Period Title: Overall Study
Started 35 [1] 29 [1]
Completed 6 [2] 5 [2]
Not Completed 29 24
Reason Not Completed
Condition under investigation worsened             11             13
Adverse Event             15             11
Other             1             0
Never received IP             2             0
[1]
randomised patients
[2]
ongoing study treatment at data cut-off
Arm/Group Title Vandetanib Plus Docetaxel Placebo Plus Docetaxel Total
Hide Arm/Group Description vandetanib 100 mg plus docetaxel placebo plus docetaxel Total of all reporting groups
Overall Number of Baseline Participants 35 29 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants 29 participants 64 participants
54
(33 to 80)
57
(39 to 74)
55.5
(33 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 29 participants 64 participants
Female
35
 100.0%
29
 100.0%
64
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Patients With a 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 (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
vandetanib 100 mg plus docetaxel
placebo plus docetaxel
Overall Number of Participants Analyzed 35 29
Measure Type: Number
Unit of Measure: Participants
24 18
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description vandetanib 100 mg plus docetaxel placebo plus docetaxel
All-Cause Mortality
Vandetanib Plus Docetaxel Placebo Plus Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib Plus Docetaxel Placebo Plus Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   14/33 (42.42%)   12/29 (41.38%) 
Blood and lymphatic system disorders     
Neutropenia  1  4/33 (12.12%)  2/29 (6.90%) 
Febrile Neutropenia  1  3/33 (9.09%)  1/29 (3.45%) 
Granulocytopenia  1  0/33 (0.00%)  1/29 (3.45%) 
Cardiac disorders     
Atrial Fibrillation  1  1/33 (3.03%)  1/29 (3.45%) 
Ear and labyrinth disorders     
Vertigo  1  1/33 (3.03%)  0/29 (0.00%) 
Eye disorders     
Keratitis  1  1/33 (3.03%)  0/29 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  3/33 (9.09%)  0/29 (0.00%) 
Colitis  1  0/33 (0.00%)  1/29 (3.45%) 
Ileus  1  1/33 (3.03%)  0/29 (0.00%) 
Nausea  1  1/33 (3.03%)  0/29 (0.00%) 
Stomatitis  1  1/33 (3.03%)  0/29 (0.00%) 
General disorders     
Asthenia  1  1/33 (3.03%)  0/29 (0.00%) 
Fatigue  1  1/33 (3.03%)  0/29 (0.00%) 
Pyrexia  1  0/33 (0.00%)  1/29 (3.45%) 
Infections and infestations     
Neutropenic Sepsis  1  0/33 (0.00%)  2/29 (6.90%) 
Cellulitis  1  1/33 (3.03%)  0/29 (0.00%) 
Pharyngitis Streptococcal  1  0/33 (0.00%)  1/29 (3.45%) 
Pneumonia  1  1/33 (3.03%)  1/29 (3.45%) 
Tooth Abscess  1  0/33 (0.00%)  1/29 (3.45%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  1/33 (3.03%)  0/29 (0.00%) 
Nervous system disorders     
Vocal Cord Paralysis  1  0/33 (0.00%)  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/33 (0.00%)  3/29 (10.34%) 
Hydrothorax  1  0/33 (0.00%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders     
Dermatitis Exfoliative  1  1/33 (3.03%)  0/29 (0.00%) 
Rash Papular  1  1/33 (3.03%)  0/29 (0.00%) 
Toxic Epidermal Necrolysis  1  1/33 (3.03%)  0/29 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis  1  0/33 (0.00%)  1/29 (3.45%) 
Hypertension  1  1/33 (3.03%)  0/29 (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 Plus Docetaxel Placebo Plus Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   33/33 (100.00%)   25/29 (86.21%) 
Blood and lymphatic system disorders     
Neutropenia  1  15/33 (45.45%)  13/29 (44.83%) 
Leukopenia  1  10/33 (30.30%)  8/29 (27.59%) 
Anaemia  1  6/33 (18.18%)  6/29 (20.69%) 
Thrombocytopenia  1  4/33 (12.12%)  0/29 (0.00%) 
Febrile Neutropenia  1  3/33 (9.09%)  0/29 (0.00%) 
Lymphopenia  1  3/33 (9.09%)  2/29 (6.90%) 
Agranulocytosis  1  2/33 (6.06%)  2/29 (6.90%) 
Ear and labyrinth disorders     
Vertigo  1  2/33 (6.06%)  1/29 (3.45%) 
Eye disorders     
Lacrimation Increased  1  2/33 (6.06%)  7/29 (24.14%) 
Conjunctivitis  1  2/33 (6.06%)  3/29 (10.34%) 
Vision Blurred  1  0/33 (0.00%)  2/29 (6.90%) 
Gastrointestinal disorders     
Stomatitis  1  16/33 (48.48%)  12/29 (41.38%) 
Diarrhoea  1  13/33 (39.39%)  12/29 (41.38%) 
Nausea  1  9/33 (27.27%)  10/29 (34.48%) 
Abdominal Pain  1  6/33 (18.18%)  5/29 (17.24%) 
Vomiting  1  3/33 (9.09%)  6/29 (20.69%) 
Constipation  1  5/33 (15.15%)  2/29 (6.90%) 
Dry Mouth  1  4/33 (12.12%)  1/29 (3.45%) 
Cheilitis  1  1/33 (3.03%)  3/29 (10.34%) 
Dyspepsia  1  3/33 (9.09%)  3/29 (10.34%) 
Flatulence  1  2/33 (6.06%)  1/29 (3.45%) 
Gastritis  1  2/33 (6.06%)  2/29 (6.90%) 
Mouth Ulceration  1  0/33 (0.00%)  2/29 (6.90%) 
Odynophagia  1  2/33 (6.06%)  0/29 (0.00%) 
General disorders     
Fatigue  1  11/33 (33.33%)  7/29 (24.14%) 
Asthenia  1  3/33 (9.09%)  8/29 (27.59%) 
Oedema Peripheral  1  7/33 (21.21%)  6/29 (20.69%) 
Pyrexia  1  5/33 (15.15%)  3/29 (10.34%) 
Face Oedema  1  1/33 (3.03%)  2/29 (6.90%) 
Influenza Like Illness  1  1/33 (3.03%)  2/29 (6.90%) 
Malaise  1  2/33 (6.06%)  0/29 (0.00%) 
Performance Status Decreased  1  2/33 (6.06%)  0/29 (0.00%) 
Infections and infestations     
Pharyngitis  1  2/33 (6.06%)  3/29 (10.34%) 
Upper Respiratory Tract Infection  1  0/33 (0.00%)  3/29 (10.34%) 
Herpes Zoster  1  0/33 (0.00%)  2/29 (6.90%) 
Nasopharyngitis  1  2/33 (6.06%)  1/29 (3.45%) 
Oral Candidiasis  1  1/33 (3.03%)  2/29 (6.90%) 
Urinary Tract Infection  1  2/33 (6.06%)  0/29 (0.00%) 
Injury, poisoning and procedural complications     
Chemical Eye Injury  1  2/33 (6.06%)  2/29 (6.90%) 
Weight Decreased  1  3/33 (9.09%)  2/29 (6.90%) 
Alanine Aminotransferase Increased  1  2/33 (6.06%)  2/29 (6.90%) 
Aspartate Aminotransferase Increased  1  2/33 (6.06%)  2/29 (6.90%) 
Blood Alkaline Phosphatase Increased  1  2/33 (6.06%)  1/29 (3.45%) 
Metabolism and nutrition disorders     
Anorexia  1  7/33 (21.21%)  9/29 (31.03%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  10/33 (30.30%)  9/29 (31.03%) 
Bone Pain  1  0/33 (0.00%)  4/29 (13.79%) 
Arthralgia  1  3/33 (9.09%)  2/29 (6.90%) 
Pain In Extremity  1  2/33 (6.06%)  3/29 (10.34%) 
Back Pain  1  1/33 (3.03%)  2/29 (6.90%) 
Musculoskeletal Chest Pain  1  2/33 (6.06%)  0/29 (0.00%) 
Musculoskeletal Pain  1  1/33 (3.03%)  2/29 (6.90%) 
Nervous system disorders     
Paraesthesia  1  4/33 (12.12%)  9/29 (31.03%) 
Peripheral Sensory Neuropathy  1  6/33 (18.18%)  3/29 (10.34%) 
Dysgeusia  1  5/33 (15.15%)  4/29 (13.79%) 
Headache  1  4/33 (12.12%)  4/29 (13.79%) 
Hypoaesthesia  1  4/33 (12.12%)  3/29 (10.34%) 
Dizziness  1  3/33 (9.09%)  2/29 (6.90%) 
Lethargy  1  3/33 (9.09%)  3/29 (10.34%) 
Neurotoxicity  1  2/33 (6.06%)  1/29 (3.45%) 
Psychiatric disorders     
Insomnia  1  3/33 (9.09%)  2/29 (6.90%) 
Depression  1  2/33 (6.06%)  1/29 (3.45%) 
Renal and urinary disorders     
Dysuria  1  2/33 (6.06%)  1/29 (3.45%) 
Reproductive system and breast disorders     
Vaginal Discharge  1  0/33 (0.00%)  2/29 (6.90%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/33 (24.24%)  3/29 (10.34%) 
Dyspnoea  1  6/33 (18.18%)  4/29 (13.79%) 
Pharyngolaryngeal Pain  1  5/33 (15.15%)  1/29 (3.45%) 
Epistaxis  1  4/33 (12.12%)  0/29 (0.00%) 
Rhinorrhoea  1  2/33 (6.06%)  1/29 (3.45%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  17/33 (51.52%)  11/29 (37.93%) 
Erythema  1  7/33 (21.21%)  4/29 (13.79%) 
Onycholysis  1  6/33 (18.18%)  1/29 (3.45%) 
Dry Skin  1  5/33 (15.15%)  5/29 (17.24%) 
Rash Maculo-Papular  1  5/33 (15.15%)  0/29 (0.00%) 
Skin Exfoliation  1  2/33 (6.06%)  5/29 (17.24%) 
Dermatitis Acneiform  1  3/33 (9.09%)  4/29 (13.79%) 
Acne  1  3/33 (9.09%)  1/29 (3.45%) 
Nail Discolouration  1  3/33 (9.09%)  0/29 (0.00%) 
Nail Pigmentation  1  3/33 (9.09%)  3/29 (10.34%) 
Palmar-Plantar Erythrodysaesthesia Syndrome  1  3/33 (9.09%)  0/29 (0.00%) 
Rash Erythematous  1  1/33 (3.03%)  3/29 (10.34%) 
Skin Hyperpigmentation  1  3/33 (9.09%)  3/29 (10.34%) 
Nail Disorder  1  2/33 (6.06%)  2/29 (6.90%) 
Pigmentation Disorder  1  2/33 (6.06%)  0/29 (0.00%) 
Rash  1  2/33 (6.06%)  1/29 (3.45%) 
Rash Pruritic  1  2/33 (6.06%)  0/29 (0.00%) 
Vascular disorders     
Hypertension  1  5/33 (15.15%)  0/29 (0.00%) 
Flushing  1  2/33 (6.06%)  2/29 (6.90%) 
Hot Flush  1  0/33 (0.00%)  2/29 (6.90%) 
Lymphoedema  1  0/33 (0.00%)  2/29 (6.90%) 
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 ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00494481     History of Changes
Other Study ID Numbers: D4200C00046
2005-003592-20 ( EudraCT Number )
First Submitted: June 28, 2007
First Posted: June 29, 2007
Results First Submitted: April 27, 2011
Results First Posted: May 24, 2011
Last Update Posted: September 30, 2016