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Trial record 1 of 1 for:    D4200C00047
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A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00500292
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : May 24, 2011
Last Update Posted : January 25, 2018
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
Conditions Colorectal
Cancer
Interventions Drug: Vandetanib
Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
Enrollment 109
Recruitment Details First patient randomised 19 March 2007, last patient randomised 11 Nov 2007, data cut off date 8 March 2008. 109 patients were enrolled in the study.
Pre-assignment Details 109 patients were enrolled/screened to the study but only 104 patients were entered treatment/randomized.
Arm/Group Title Vandetanib 100 mg Plus FOLFOX Vandetanib 300 mg Plus FOLFOX Placebo Plus FOLFOX
Hide Arm/Group Description vandetanib 100 mg plus FOLFOX vandetanib 300 mg plus FOLFOX placebo plus FOLFOX
Period Title: Overall Study
Started 32 [1] 35 [1] 37 [1]
Completed 7 [2] 4 [2] 10 [2]
Not Completed 25 31 27
Reason Not Completed
Adverse Event             3             6             4
Condition under investigation worsened             21             23             19
Withdrawal by Subject             0             1             0
Other             1             1             4
[1]
randomised patients
[2]
Ongoing study treatment at data cut-off date 8 March 2008.
Arm/Group Title Vandetanib 100 mg Plus FOLFOX Vandetanib 300 mg Plus FOLFOX Placebo Plus FOLFOX Total
Hide Arm/Group Description vandetanib 100 mg plus FOLFOX vandetanib 300 mg plus FOLFOX placebo plus FOLFOX Total of all reporting groups
Overall Number of Baseline Participants 32 35 37 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants 35 participants 37 participants 104 participants
57
(34 to 75)
58
(37 to 71)
59
(32 to 81)
58
(32 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 35 participants 37 participants 104 participants
Female
16
  50.0%
11
  31.4%
13
  35.1%
40
  38.5%
Male
16
  50.0%
24
  68.6%
24
  64.9%
64
  61.5%
1.Primary 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 (5 March 2008 +/-3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus FOLFOX Vandetanib 300 mg Plus FOLFOX Placebo Plus FOLFOX
Hide Arm/Group Description:
vandetanib 100 mg plus FOLFOX
vandetanib 300 mg plus FOLFOX
placebo plus FOLFOX
Overall Number of Participants Analyzed 32 35 37
Measure Type: Number
Unit of Measure: Participants
23 27 24
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib 100 mg Vandetanib 300 mg Placebo
Hide Arm/Group Description vandetanib 100 mg plus FOLFOX vandetanib 300 mg plus FOLFOX placebo plus FOLFOX
All-Cause Mortality
Vandetanib 100 mg Vandetanib 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib 100 mg Vandetanib 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/32 (18.75%)   10/35 (28.57%)   4/37 (10.81%) 
Cardiac disorders       
Angina Pectoris  1  0/32 (0.00%)  0/35 (0.00%)  1/37 (2.70%) 
Gastrointestinal disorders       
Diarrhoea  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Ileus  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Intestinal Obstruction  1  0/32 (0.00%)  0/35 (0.00%)  1/37 (2.70%) 
Subileus  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Vomiting  1  0/32 (0.00%)  0/35 (0.00%)  1/37 (2.70%) 
General disorders       
Mucosal Inflammation  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Pyrexia  1  0/32 (0.00%)  1/35 (2.86%)  1/37 (2.70%) 
Immune system disorders       
Anaphylactic Reaction  1  0/32 (0.00%)  0/35 (0.00%)  1/37 (2.70%) 
Infections and infestations       
Appendicitis  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Device Related Infection  1  2/32 (6.25%)  0/35 (0.00%)  0/37 (0.00%) 
Lung Abscess  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Pneumonia  1  1/32 (3.13%)  3/35 (8.57%)  0/37 (0.00%) 
Staphylococcal Infection  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Staphylococcal Sepsis  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  1  1/32 (3.13%)  0/35 (0.00%)  0/37 (0.00%) 
Metabolism and nutrition disorders       
Decreased Appetite  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Hypomagnesaemia  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma Gastric  1  1/32 (3.13%)  0/35 (0.00%)  0/37 (0.00%) 
Nervous system disorders       
Haemorrhage Intracranial  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Reproductive system and breast disorders       
Female Genital Tract Fistula  1  1/32 (3.13%)  0/35 (0.00%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders       
Toxic Epidermal Necrolysis  1  0/32 (0.00%)  1/35 (2.86%)  0/37 (0.00%) 
Vascular disorders       
Hypertension  1  1/32 (3.13%)  0/35 (0.00%)  0/37 (0.00%) 
Venous Thrombosis  1  1/32 (3.13%)  0/35 (0.00%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 20.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib 100 mg Vandetanib 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/32 (96.88%)   32/35 (91.43%)   35/37 (94.59%) 
Blood and lymphatic system disorders       
Leukopenia  1  4/32 (12.50%)  5/35 (14.29%)  5/37 (13.51%) 
Neutropenia  1  13/32 (40.63%)  11/35 (31.43%)  13/37 (35.14%) 
Thrombocytopenia  1  16/32 (50.00%)  18/35 (51.43%)  13/37 (35.14%) 
Cardiac disorders       
Tachycardia  1  0/32 (0.00%)  0/35 (0.00%)  2/37 (5.41%) 
Eye disorders       
Vision Blurred  1  0/32 (0.00%)  2/35 (5.71%)  1/37 (2.70%) 
Gastrointestinal disorders       
Abdominal Distension  1  2/32 (6.25%)  3/35 (8.57%)  2/37 (5.41%) 
Abdominal Pain  1  2/32 (6.25%)  3/35 (8.57%)  10/37 (27.03%) 
Abdominal Pain Upper  1  2/32 (6.25%)  1/35 (2.86%)  4/37 (10.81%) 
Constipation  1  6/32 (18.75%)  3/35 (8.57%)  6/37 (16.22%) 
Diarrhoea  1  16/32 (50.00%)  22/35 (62.86%)  16/37 (43.24%) 
Epigastric Discomfort  1  0/32 (0.00%)  2/35 (5.71%)  0/37 (0.00%) 
Flatulence  1  0/32 (0.00%)  0/35 (0.00%)  2/37 (5.41%) 
Gingival Bleeding  1  0/32 (0.00%)  2/35 (5.71%)  0/37 (0.00%) 
Nausea  1  13/32 (40.63%)  15/35 (42.86%)  24/37 (64.86%) 
Rectal Haemorrhage  1  0/32 (0.00%)  0/35 (0.00%)  2/37 (5.41%) 
Stomatitis  1  8/32 (25.00%)  11/35 (31.43%)  10/37 (27.03%) 
Toothache  1  0/32 (0.00%)  1/35 (2.86%)  2/37 (5.41%) 
Vomiting  1  9/32 (28.13%)  5/35 (14.29%)  14/37 (37.84%) 
General disorders       
Asthenia  1  4/32 (12.50%)  8/35 (22.86%)  6/37 (16.22%) 
Chills  1  1/32 (3.13%)  1/35 (2.86%)  2/37 (5.41%) 
Fatigue  1  8/32 (25.00%)  10/35 (28.57%)  15/37 (40.54%) 
Oedema Peripheral  1  1/32 (3.13%)  2/35 (5.71%)  1/37 (2.70%) 
Pyrexia  1  3/32 (9.38%)  5/35 (14.29%)  9/37 (24.32%) 
Hepatobiliary disorders       
Hepatotoxicity  1  0/32 (0.00%)  2/35 (5.71%)  0/37 (0.00%) 
Hyperbilirubinaemia  1  0/32 (0.00%)  0/35 (0.00%)  2/37 (5.41%) 
Immune system disorders       
Drug Hypersensitivity  1  3/32 (9.38%)  4/35 (11.43%)  5/37 (13.51%) 
Infections and infestations       
Bronchitis  1  0/32 (0.00%)  2/35 (5.71%)  1/37 (2.70%) 
Nasopharyngitis  1  4/32 (12.50%)  1/35 (2.86%)  2/37 (5.41%) 
Pharyngitis  1  2/32 (6.25%)  1/35 (2.86%)  0/37 (0.00%) 
Investigations       
Electrocardiogram Qt Prolonged  1  1/32 (3.13%)  6/35 (17.14%)  1/37 (2.70%) 
Weight Decreased  1  3/32 (9.38%)  1/35 (2.86%)  2/37 (5.41%) 
Metabolism and nutrition disorders       
Anorexia  1  10/32 (31.25%)  11/35 (31.43%)  9/37 (24.32%) 
Decreased Appetite  1  0/32 (0.00%)  0/35 (0.00%)  2/37 (5.41%) 
Musculoskeletal and connective tissue disorders       
Back Pain  1  5/32 (15.63%)  4/35 (11.43%)  4/37 (10.81%) 
Musculoskeletal Pain  1  2/32 (6.25%)  0/35 (0.00%)  1/37 (2.70%) 
Nervous system disorders       
Dizziness  1  2/32 (6.25%)  2/35 (5.71%)  3/37 (8.11%) 
Dysaesthesia  1  1/32 (3.13%)  1/35 (2.86%)  3/37 (8.11%) 
Dysgeusia  1  0/32 (0.00%)  0/35 (0.00%)  2/37 (5.41%) 
Headache  1  2/32 (6.25%)  5/35 (14.29%)  2/37 (5.41%) 
Lethargy  1  2/32 (6.25%)  0/35 (0.00%)  1/37 (2.70%) 
Paraesthesia  1  4/32 (12.50%)  5/35 (14.29%)  3/37 (8.11%) 
Peripheral Sensory Neuropathy  1  16/32 (50.00%)  12/35 (34.29%)  18/37 (48.65%) 
Psychiatric disorders       
Anxiety  1  0/32 (0.00%)  3/35 (8.57%)  0/37 (0.00%) 
Confusional State  1  0/32 (0.00%)  2/35 (5.71%)  0/37 (0.00%) 
Insomnia  1  3/32 (9.38%)  3/35 (8.57%)  3/37 (8.11%) 
Renal and urinary disorders       
Dysuria  1  0/32 (0.00%)  2/35 (5.71%)  1/37 (2.70%) 
Haematuria  1  0/32 (0.00%)  2/35 (5.71%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  6/32 (18.75%)  1/35 (2.86%)  3/37 (8.11%) 
Dyspnoea  1  3/32 (9.38%)  4/35 (11.43%)  2/37 (5.41%) 
Epistaxis  1  2/32 (6.25%)  3/35 (8.57%)  4/37 (10.81%) 
Pharyngolaryngeal Pain  1  2/32 (6.25%)  1/35 (2.86%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne  1  3/32 (9.38%)  2/35 (5.71%)  3/37 (8.11%) 
Alopecia  1  3/32 (9.38%)  1/35 (2.86%)  3/37 (8.11%) 
Dermatitis Acneiform  1  1/32 (3.13%)  5/35 (14.29%)  1/37 (2.70%) 
Dry Skin  1  2/32 (6.25%)  2/35 (5.71%)  1/37 (2.70%) 
Hyperhidrosis  1  0/32 (0.00%)  2/35 (5.71%)  0/37 (0.00%) 
Palmar-Plantar Erythrodysaesthesia Syndrome  1  3/32 (9.38%)  3/35 (8.57%)  1/37 (2.70%) 
Photosensitivity Reaction  1  3/32 (9.38%)  7/35 (20.00%)  1/37 (2.70%) 
Pigmentation Disorder  1  1/32 (3.13%)  2/35 (5.71%)  1/37 (2.70%) 
Pruritus  1  1/32 (3.13%)  2/35 (5.71%)  3/37 (8.11%) 
Rash  1  7/32 (21.88%)  7/35 (20.00%)  3/37 (8.11%) 
Urticaria  1  1/32 (3.13%)  0/35 (0.00%)  2/37 (5.41%) 
Vascular disorders       
Hypertension  1  13/32 (40.63%)  13/35 (37.14%)  5/37 (13.51%) 
Phlebitis  1  2/32 (6.25%)  1/35 (2.86%)  1/37 (2.70%) 
Phlebitis Superficial  1  2/32 (6.25%)  1/35 (2.86%)  0/37 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 20.0
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: NCT00500292     History of Changes
Other Study ID Numbers: D4200C00047
2006-005022-23 ( EudraCT Number )
LPS15025 ( Other Identifier: Sanofi )
First Submitted: July 3, 2007
First Posted: July 12, 2007
Results First Submitted: April 27, 2011
Results First Posted: May 24, 2011
Last Update Posted: January 25, 2018