A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Com... | NCT00500292

ID	Type	Description	Link
2006-005022-23	EudraCT Number
LPS15025	Other Identifier	Sanofi

Official Title

A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	FOLFOX + Placebo vandetanib	Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
2	Experimental	FOLFOX + low dose vandetanib	Drug: Vandetanib Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
3	Experimental	FOLFOX + high dose vandetanib	Drug: Vandetanib Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid

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

Outcomes Module

Primary Outcomes

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)	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)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lille			France
Research Site

References Module

Label	URL
Related Info	View source
CSR-D4200C00047.pdf	View source

Results Section

Participant Flow Module

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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

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

Units	Counts
Participants	BG00032 BG00135 BG00237 BG003104

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

Years

Title

Denominators

Categories

Title	Measurements
	OG00023 OG00127 OG00224

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Vandetanib 100 mg	vandetanib 100 mg plus FOLFOX	6	32	31	32
EG001	Vandetanib 300 mg	vandetanib 300 mg plus FOLFOX	10	35	32	35
EG002	Placebo	placebo plus FOLFOX	4	37	35	37

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Pectoris	Cardiac disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0021 affected37 at risk
Diarrhoea	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Ileus	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0021 affected37 at risk
Subileus	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0021 affected37 at risk
Mucosal Inflammation	General disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Pyrexia	General disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0021 affected37 at risk
Anaphylactic Reaction	Immune system disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0021 affected37 at risk
Appendicitis	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Device Related Infection	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected35 at risk EG0020 affected37 at risk
Lung Abscess	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Pneumonia	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0013 affected35 at risk EG0020 affected37 at risk
Staphylococcal Infection	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Staphylococcal Sepsis	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Contusion	Injury, poisoning and procedural complications	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected35 at risk EG0020 affected37 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Adenocarcinoma Gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected35 at risk EG0020 affected37 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Female Genital Tract Fistula	Reproductive system and breast disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected35 at risk EG0020 affected37 at risk
Toxic Epidermal Necrolysis	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Hypertension	Vascular disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected35 at risk EG0020 affected37 at risk
Venous Thrombosis	Vascular disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected35 at risk EG0020 affected37 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDra 20.0	Systematic Assessment	EG0004 affected32 at risk EG0015 affected35 at risk EG0025 affected37 at risk
Neutropenia	Blood and lymphatic system disorders	MedDra 20.0	Systematic Assessment	EG00013 affected32 at risk EG00111 affected35 at risk EG00213 affected37 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDra 20.0	Systematic Assessment	EG00016 affected32 at risk EG00118 affected35 at risk EG00213 affected37 at risk
Tachycardia	Cardiac disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0022 affected37 at risk
Vision Blurred	Eye disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0021 affected37 at risk
Abdominal Distension	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0013 affected35 at risk EG0022 affected37 at risk
Abdominal Pain	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0013 affected35 at risk EG00210 affected37 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected35 at risk EG0024 affected37 at risk
Constipation	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0006 affected32 at risk EG0013 affected35 at risk EG0026 affected37 at risk
Diarrhoea	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG00016 affected32 at risk EG00122 affected35 at risk EG00216 affected37 at risk
Epigastric Discomfort	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0020 affected37 at risk
Flatulence	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0022 affected37 at risk
Gingival Bleeding	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0020 affected37 at risk
Nausea	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG00013 affected32 at risk EG00115 affected35 at risk EG00224 affected37 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0022 affected37 at risk
Stomatitis	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0008 affected32 at risk EG00111 affected35 at risk EG00210 affected37 at risk
Toothache	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0011 affected35 at risk EG0022 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDra 20.0	Systematic Assessment	EG0009 affected32 at risk EG0015 affected35 at risk EG00214 affected37 at risk
Asthenia	General disorders	MedDra 20.0	Systematic Assessment	EG0004 affected32 at risk EG0018 affected35 at risk EG0026 affected37 at risk
Chills	General disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected35 at risk EG0022 affected37 at risk
Fatigue	General disorders	MedDra 20.0	Systematic Assessment	EG0008 affected32 at risk EG00110 affected35 at risk EG00215 affected37 at risk
Oedema Peripheral	General disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0012 affected35 at risk EG0021 affected37 at risk
Pyrexia	General disorders	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0015 affected35 at risk EG0029 affected37 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0020 affected37 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0022 affected37 at risk
Drug Hypersensitivity	Immune system disorders	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0014 affected35 at risk EG0025 affected37 at risk
Bronchitis	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0021 affected37 at risk
Nasopharyngitis	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0004 affected32 at risk EG0011 affected35 at risk EG0022 affected37 at risk
Pharyngitis	Infections and infestations	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Electrocardiogram Qt Prolonged	Investigations	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0016 affected35 at risk EG0021 affected37 at risk
Weight Decreased	Investigations	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0011 affected35 at risk EG0022 affected37 at risk
Anorexia	Metabolism and nutrition disorders	MedDra 20.0	Systematic Assessment	EG00010 affected32 at risk EG00111 affected35 at risk EG0029 affected37 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0022 affected37 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDra 20.0	Systematic Assessment	EG0005 affected32 at risk EG0014 affected35 at risk EG0024 affected37 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected35 at risk EG0021 affected37 at risk
Dizziness	Nervous system disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0012 affected35 at risk EG0023 affected37 at risk
Dysaesthesia	Nervous system disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0011 affected35 at risk EG0023 affected37 at risk
Dysgeusia	Nervous system disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0010 affected35 at risk EG0022 affected37 at risk
Headache	Nervous system disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0015 affected35 at risk EG0022 affected37 at risk
Lethargy	Nervous system disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0010 affected35 at risk EG0021 affected37 at risk
Paraesthesia	Nervous system disorders	MedDra 20.0	Systematic Assessment	EG0004 affected32 at risk EG0015 affected35 at risk EG0023 affected37 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDra 20.0	Systematic Assessment	EG00016 affected32 at risk EG00112 affected35 at risk EG00218 affected37 at risk
Anxiety	Psychiatric disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0013 affected35 at risk EG0020 affected37 at risk
Confusional State	Psychiatric disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0020 affected37 at risk
Insomnia	Psychiatric disorders	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0013 affected35 at risk EG0023 affected37 at risk
Dysuria	Renal and urinary disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0021 affected37 at risk
Haematuria	Renal and urinary disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0020 affected37 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDra 20.0	Systematic Assessment	EG0006 affected32 at risk EG0011 affected35 at risk EG0023 affected37 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0014 affected35 at risk EG0022 affected37 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0013 affected35 at risk EG0024 affected37 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk
Acne	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0012 affected35 at risk EG0023 affected37 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0011 affected35 at risk EG0023 affected37 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0015 affected35 at risk EG0021 affected37 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0012 affected35 at risk EG0021 affected37 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0000 affected32 at risk EG0012 affected35 at risk EG0020 affected37 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0013 affected35 at risk EG0021 affected37 at risk
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0003 affected32 at risk EG0017 affected35 at risk EG0021 affected37 at risk
Pigmentation Disorder	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0012 affected35 at risk EG0021 affected37 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0012 affected35 at risk EG0023 affected37 at risk
Rash	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0007 affected32 at risk EG0017 affected35 at risk EG0023 affected37 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDra 20.0	Systematic Assessment	EG0001 affected32 at risk EG0010 affected35 at risk EG0022 affected37 at risk
Hypertension	Vascular disorders	MedDra 20.0	Systematic Assessment	EG00013 affected32 at risk EG00113 affected35 at risk EG0025 affected37 at risk
Phlebitis	Vascular disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected35 at risk EG0021 affected37 at risk
Phlebitis Superficial	Vascular disorders	MedDra 20.0	Systematic Assessment	EG0002 affected32 at risk EG0011 affected35 at risk EG0020 affected37 at risk

Ancestor Terms

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes

ID	Term
C452423	vandetanib
D005472	Fluorouracil
D002955	Leucovorin