A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6... | NCT00454116

ID	Type	Description	Link
2006-005023-42	EudraCT Number

Label	Type	Description	Intervention Names
1	Placebo Comparator	FOLFIRI + placebo vandetanib	Drug: FOLFIRI
2	Experimental	FOLFIRI + low dose vandetanib	Drug: Vandetanib Drug: FOLFIRI
3	Experimental	FOLFIRI + high dose vandetanib	Drug: Vandetanib Drug: FOLFIRI

Name	Type	Description	Arm Group Labels	Other Names
Vandetanib	Drug	once daily oral tablet two doses	2 3

Measure	Description	Time Frame
Number of Patients With an Objective Disease Progression Event	Number of patients with objective disease progression or death (by any cause in the absence of objective progression)	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 (28 March 2008 +/-3 days)

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Ann Arbor	Michigan		United States
Research Site

ID	Title	Description
FG000	Vandetanib 100 mg Plus FOLFIRI	vandetanib 100 mg plus FOLFIRI
FG001	Vandetanib 300 mg Plus FOLFIRI	vandetanib 300 mg plus FOLFIRI

ID	Title	Description
BG000	Vandetanib 100 mg Plus FOLFIRI	vandetanib 100 mg plus FOLFIRI
BG001	Vandetanib 300 mg Plus FOLFIRI	vandetanib 300 mg plus FOLFIRI
BG002	Placebo Plus FOLFIRI	placebo plus FOLFIRI
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00035 BG00136 BG00235 BG003106

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0022 affected35 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0013 affected36 at risk EG0022 affected35 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0022 affected35 at risk
ILEUS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected36 at risk EG0020 affected35 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
PROCTITIS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected36 at risk EG0020 affected35 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
PYREXIA	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0013 affected36 at risk EG0023 affected35 at risk
CHEST PAIN	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected36 at risk EG0020 affected35 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
CELLULITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected36 at risk EG0020 affected35 at risk
EPSTEIN-BARR VIRUS INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
PNEUMONIA	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0021 affected35 at risk
SEPSIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
PHOTOSENSITIVITY REACTION	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0010 affected36 at risk EG0020 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG00016 affected35 at risk EG00117 affected36 at risk EG00219 affected35 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0016 affected36 at risk EG0023 affected35 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0012 affected36 at risk EG0024 affected35 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0012 affected36 at risk EG0023 affected35 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00018 affected35 at risk EG00126 affected36 at risk EG00217 affected35 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00017 affected35 at risk EG00112 affected36 at risk EG00218 affected35 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00010 affected35 at risk EG00115 affected36 at risk EG00216 affected35 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0009 affected35 at risk EG0016 affected36 at risk EG00212 affected35 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected35 at risk EG0014 affected36 at risk EG0028 affected35 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0007 affected35 at risk EG0016 affected36 at risk EG0027 affected35 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0004 affected35 at risk EG0016 affected36 at risk EG0026 affected35 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0011 affected36 at risk EG0023 affected35 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
ORAL PAIN	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0012 affected36 at risk EG0021 affected35 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0022 affected35 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
PROCTALGIA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
FATIGUE	General disorders	MedDRA 10.1	Systematic Assessment	EG00010 affected35 at risk EG0019 affected36 at risk EG0029 affected35 at risk
ASTHENIA	General disorders	MedDRA 10.1	Systematic Assessment	EG0007 affected35 at risk EG0016 affected36 at risk EG0026 affected35 at risk
PYREXIA	General disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected35 at risk EG0013 affected36 at risk EG0023 affected35 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0013 affected36 at risk EG0023 affected35 at risk
CHILLS	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0011 affected36 at risk EG0022 affected35 at risk
INJECTION SITE REACTION	General disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
CENTRAL LINE INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0014 affected36 at risk EG0022 affected35 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0014 affected36 at risk EG0020 affected35 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0003 affected35 at risk EG0011 affected36 at risk EG0021 affected35 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0013 affected36 at risk EG0022 affected35 at risk
ELECTROCARDIOGRAM QT PROLONGED	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0004 affected35 at risk EG0018 affected36 at risk EG0021 affected35 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG00011 affected35 at risk EG00110 affected36 at risk EG00215 affected35 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0011 affected36 at risk EG0023 affected35 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0013 affected36 at risk EG0021 affected35 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0014 affected36 at risk EG0022 affected35 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
LETHARGY	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0005 affected35 at risk EG0012 affected36 at risk EG0024 affected35 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0012 affected36 at risk EG0025 affected35 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0014 affected36 at risk EG0024 affected35 at risk
HEADACHE	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0013 affected36 at risk EG0021 affected35 at risk
CHOLINERGIC SYNDROME	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0021 affected35 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0012 affected36 at risk EG0022 affected35 at risk
INSOMNIA	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0005 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
ANXIETY	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0013 affected36 at risk EG0022 affected35 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0013 affected36 at risk EG0020 affected35 at risk
DYSURIA	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected35 at risk EG0013 affected36 at risk EG0023 affected35 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0014 affected36 at risk EG0022 affected35 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected35 at risk EG0014 affected36 at risk EG0022 affected35 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0013 affected36 at risk EG0020 affected35 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0012 affected36 at risk EG0022 affected35 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0008 affected35 at risk EG00122 affected36 at risk EG0026 affected35 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG00012 affected35 at risk EG00110 affected36 at risk EG00215 affected35 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0015 affected36 at risk EG0022 affected35 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0014 affected36 at risk EG0022 affected35 at risk
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0012 affected36 at risk EG0022 affected35 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0021 affected35 at risk
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0021 affected35 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0011 affected36 at risk EG0020 affected35 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected35 at risk EG0011 affected36 at risk EG0022 affected35 at risk
PHOTOSENSITIVITY REACTION	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected35 at risk EG0010 affected36 at risk EG0020 affected35 at risk
SKIN EXFOLIATION	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected35 at risk EG0014 affected36 at risk EG0022 affected35 at risk
SALIVARY HYPERSECRETION	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0022 affected35 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0022 affected35 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA (10.1)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
VISION BLURRED	Eye disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0011 affected36 at risk EG0022 affected35 at risk
SKIN INFECTION	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0002 affected35 at risk EG0010 affected36 at risk EG0021 affected35 at risk
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
HAEMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk
NAIL DISORDER	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0010 affected36 at risk EG0022 affected35 at risk
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected35 at risk EG0012 affected36 at risk EG0020 affected35 at risk

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vandetanib 100 mg Plus FOLFIRI	vandetanib 100 mg plus FOLFIRI	8	35	32	35
EG001	Vandetanib 300 mg Plus FOLFIRI	vandetanib 300 mg plus FOLFIRI	13	36	36	36
EG002	Placebo Plus FOLFIRI	placebo plus FOLFIRI	12	35	34	35