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Trial Outcomes & Findings for ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer (NCT NCT00312377)

NCT ID: NCT00312377

Last Updated: 2016-09-30

Results Overview

Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1690 participants

Primary outcome timeframe

RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months

Results posted on

2016-09-30

Participant Flow

First patient enrolled 08 May 2006, last patient enrolled 14 March 2008, cut off date 22 August 2008

Participant milestones

Participant milestones
Measure
Vandetanib 100 mg Plus Docetaxel
Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
Placebo Plus Docetaxel
Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
Overall Study
STARTED
694
697
Overall Study
COMPLETED
50
29
Overall Study
NOT COMPLETED
644
668

Reasons for withdrawal

Reasons for withdrawal
Measure
Vandetanib 100 mg Plus Docetaxel
Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
Placebo Plus Docetaxel
Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
Overall Study
Death
403
418
Overall Study
Withdrawal by Subject
23
30
Overall Study
Lost to Follow-up
9
12
Overall Study
Non-compliance
0
2
Overall Study
Randomised but never received treatment
6
6
Overall Study
Discontinue treatment survival follow up
202
200
Overall Study
Site ended participation in study
1
0

Baseline Characteristics

ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 Participants
Placebo plus docetaxel
Total
n=1391 Participants
Total of all reporting groups
Age, Continuous
58.5 years
n=93 Participants
58.4 years
n=4 Participants
58.45 years
n=27 Participants
Sex: Female, Male
Female
497 Participants
n=93 Participants
473 Participants
n=4 Participants
970 Participants
n=27 Participants
Sex: Female, Male
Male
197 Participants
n=93 Participants
224 Participants
n=4 Participants
421 Participants
n=27 Participants

PRIMARY outcome

Timeframe: RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months

Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 Participants
Placebo plus docetaxel
Progression-Free Survival (PFS) in the Overall Population
17.3 Weeks
Interval 15.0 to 18.0
14 Weeks
Interval 12.7 to 16.9

PRIMARY outcome

Timeframe: RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months

Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=197 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=224 Participants
Placebo plus docetaxel
Progression-Free Survival (PFS) in the Female Population
20.1 Weeks
Interval 17.9 to 23.9
18.3 Weeks
Interval 15.0 to 22.1

SECONDARY outcome

Timeframe: Time to death in months

Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 Participants
Placebo plus docetaxel
Overall Survival (OS) in the Overall Population
10.6 Months
Interval 9.6 to 11.5
10 Months
Interval 9.2 to 10.8

SECONDARY outcome

Timeframe: Time to death in months

Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=197 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=224 Participants
Placebo plus docetaxel
Overall Survival (OS) in the Female Population
12.7 Months
Interval 10.5 to 17.1
14.2 Months
Interval 10.8 to 16.2

SECONDARY outcome

Timeframe: Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression

The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 Participants
Placebo plus docetaxel
Objective Response Rate (ORR)
120 Participants
71 Participants

SECONDARY outcome

Timeframe: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression

Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) \>= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD \>= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 Participants
Placebo plus docetaxel
Disease Control Rate (DCR)
413 Participants
380 Participants

SECONDARY outcome

Timeframe: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression

Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 Participants
Placebo plus docetaxel
Duration of Response (DoR)
29.9 Weeks
Interval 7.14 to 72.29
19.7 Weeks
Interval 9.71 to 41.86

SECONDARY outcome

Timeframe: FACT-L questionnaires are to be administered every 3 weeks after randomisation

The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items. Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 Participants
Placebo plus docetaxel
Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).
15 Weeks
Interval 6.1 to 82.3
11.9 Weeks
Interval 6.0 to 28.1

SECONDARY outcome

Timeframe: FACT-L questionnaires are to be administered every 3 weeks after randomisation

The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items. Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days. A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.

Outcome measures

Outcome measures
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 Participants
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 Participants
Placebo plus docetaxel
Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)
12.3 Weeks
Interval 5.9 to 36.7
11.9 Weeks
Interval 6.0 to 28.4

Adverse Events

Vandetanib 100 mg Plus Docetaxel

Serious events: 263 serious events
Other events: 637 other events
Deaths: 0 deaths

Placebo Plus Docetaxel

Serious events: 232 serious events
Other events: 630 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 participants at risk
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 participants at risk
Placebo plus docetaxel
Blood and lymphatic system disorders
Febrile Neutropenia
6.6%
46/694
5.5%
38/697
Blood and lymphatic system disorders
Neutropenia
2.3%
16/694
2.6%
18/697
Blood and lymphatic system disorders
Anaemia
0.58%
4/694
0.86%
6/697
Blood and lymphatic system disorders
Leukopenia
0.43%
3/694
0.29%
2/697
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/694
0.29%
2/697
Blood and lymphatic system disorders
Bone Marrow Failure
0.14%
1/694
0.00%
0/697
Blood and lymphatic system disorders
Febrile Bone Marrow Aplasia
0.14%
1/694
0.00%
0/697
Blood and lymphatic system disorders
Iron Deficiency Anaemia
0.14%
1/694
0.00%
0/697
Blood and lymphatic system disorders
Thrombocytopenia
0.14%
1/694
0.14%
1/697
Cardiac disorders
Atrial Fibrillation
0.43%
3/694
1.4%
10/697
Cardiac disorders
Myocardial Infarction
0.00%
0/694
0.57%
4/697
Cardiac disorders
Cardiac Arrest
0.14%
1/694
0.43%
3/697
Cardiac disorders
Cardiac Failure
0.00%
0/694
0.43%
3/697
Cardiac disorders
Acute Myocardial Infarction
0.29%
2/694
0.29%
2/697
Cardiac disorders
Atrial Flutter
0.29%
2/694
0.14%
1/697
Cardiac disorders
Angina Unstable
0.14%
1/694
0.00%
0/697
Cardiac disorders
Arrhythmia
0.00%
0/694
0.14%
1/697
Cardiac disorders
Atrioventricular Block Complete
0.14%
1/694
0.00%
0/697
Cardiac disorders
Atrioventricular Block Second Degree
0.00%
0/694
0.14%
1/697
Cardiac disorders
Cardiac Tamponade
0.00%
0/694
0.14%
1/697
Cardiac disorders
Cardio-Respiratory Arrest
0.14%
1/694
0.00%
0/697
Cardiac disorders
Extrasystoles
0.14%
1/694
0.00%
0/697
Cardiac disorders
Pericardial Effusion
0.14%
1/694
0.00%
0/697
Cardiac disorders
Pericarditis
0.00%
0/694
0.14%
1/697
Cardiac disorders
Supraventricular Tachycardia
0.14%
1/694
0.00%
0/697
Cardiac disorders
Tachyarrhythmia
0.00%
0/694
0.14%
1/697
Cardiac disorders
Tachycardia
0.14%
1/694
0.00%
0/697
Cardiac disorders
Ventricular Extrasystoles
0.00%
0/694
0.14%
1/697
Congenital, familial and genetic disorders
Hereditary Angioedema
0.14%
1/694
0.00%
0/697
Ear and labyrinth disorders
Deafness Unilateral
0.14%
1/694
0.00%
0/697
Ear and labyrinth disorders
Vertigo
0.14%
1/694
0.00%
0/697
Eye disorders
Ocular Surface Disease
0.14%
1/694
0.00%
0/697
Eye disorders
Retinal Artery Occlusion
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Diarrhoea
2.0%
14/694
1.6%
11/697
Gastrointestinal disorders
Vomiting
1.0%
7/694
1.1%
8/697
Gastrointestinal disorders
Nausea
0.72%
5/694
0.57%
4/697
Gastrointestinal disorders
Abdominal Pain Upper
0.58%
4/694
0.14%
1/697
Gastrointestinal disorders
Constipation
0.00%
0/694
0.43%
3/697
Gastrointestinal disorders
Gastric Ulcer
0.00%
0/694
0.43%
3/697
Gastrointestinal disorders
Abdominal Pain
0.29%
2/694
0.14%
1/697
Gastrointestinal disorders
Gastrointestinal Haemorrhage
0.14%
1/694
0.29%
2/697
Gastrointestinal disorders
Stomatitis
0.29%
2/694
0.00%
0/697
Gastrointestinal disorders
Appendicitis Perforated
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Ascites
0.00%
0/694
0.14%
1/697
Gastrointestinal disorders
Dyspepsia
0.00%
0/694
0.14%
1/697
Gastrointestinal disorders
Dysphagia
0.14%
1/694
0.14%
1/697
Gastrointestinal disorders
Enteritis
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Enterocolitis
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Gastric Haemorrhage
0.00%
0/694
0.14%
1/697
Gastrointestinal disorders
Gastritis
0.00%
0/694
0.14%
1/697
Gastrointestinal disorders
Gastrointestinal Inflammation
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Haematochezia
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Ileus Paralytic
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Inguinal Hernia
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Intestinal Obstruction
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Oesophageal Fistula
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Oesophageal Stenosis
0.14%
1/694
0.00%
0/697
Gastrointestinal disorders
Proctitis Haemorrhagic
0.00%
0/694
0.14%
1/697
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
0.00%
0/694
0.14%
1/697
General disorders
Pyrexia
1.9%
13/694
1.7%
12/697
General disorders
Asthenia
0.29%
2/694
0.72%
5/697
General disorders
Chest Pain
0.43%
3/694
0.00%
0/697
General disorders
Malaise
0.43%
3/694
0.00%
0/697
General disorders
Performance Status Decreased
0.43%
3/694
0.00%
0/697
General disorders
Fatigue
0.14%
1/694
0.29%
2/697
General disorders
General Physical Health Deterioration
0.14%
1/694
0.29%
2/697
General disorders
Mucosal Inflammation
0.14%
1/694
0.29%
2/697
General disorders
Chills
0.14%
1/694
0.00%
0/697
General disorders
Death
0.00%
0/694
0.14%
1/697
General disorders
Multi-Organ Failure
0.14%
1/694
0.14%
1/697
General disorders
Pain
0.14%
1/694
0.00%
0/697
General disorders
Sudden Death
0.14%
1/694
0.14%
1/697
General disorders
Systemic Inflammatory Response Syndrome
0.00%
0/694
0.14%
1/697
Immune system disorders
Anaphylactic Shock
0.14%
1/694
0.29%
2/697
Immune system disorders
Drug Hypersensitivity
0.29%
2/694
0.14%
1/697
Infections and infestations
Pneumonia
4.8%
33/694
3.7%
26/697
Infections and infestations
Respiratory Tract Infection
0.72%
5/694
0.86%
6/697
Infections and infestations
Sepsis
0.72%
5/694
0.72%
5/697
Infections and infestations
Upper Respiratory Tract Infection
0.00%
0/694
0.72%
5/697
Infections and infestations
Gastroenteritis
0.58%
4/694
0.43%
3/697
Infections and infestations
Lung Infection
0.58%
4/694
0.29%
2/697
Infections and infestations
Urinary Tract Infection
0.58%
4/694
0.43%
3/697
Infections and infestations
Lower Respiratory Tract Infection
0.43%
3/694
0.14%
1/697
Infections and infestations
Septic Shock
0.43%
3/694
0.14%
1/697
Infections and infestations
Bacterial Infection
0.29%
2/694
0.00%
0/697
Infections and infestations
Bronchitis
0.00%
0/694
0.29%
2/697
Infections and infestations
Bronchopneumonia
0.00%
0/694
0.29%
2/697
Infections and infestations
Infection
0.00%
0/694
0.29%
2/697
Infections and infestations
Neutropenic Infection
0.14%
1/694
0.29%
2/697
Infections and infestations
Urosepsis
0.29%
2/694
0.00%
0/697
Infections and infestations
Appendicitis
0.14%
1/694
0.00%
0/697
Infections and infestations
Bacteraemia
0.14%
1/694
0.00%
0/697
Infections and infestations
Bacterial Sepsis
0.14%
1/694
0.00%
0/697
Infections and infestations
Bronchopulmonary Aspergillosis
0.14%
1/694
0.00%
0/697
Infections and infestations
Catheter Related Infection
0.00%
0/694
0.14%
1/697
Infections and infestations
Cellulitis
0.14%
1/694
0.00%
0/697
Infections and infestations
Central Line Infection
0.00%
0/694
0.14%
1/697
Infections and infestations
Diverticulitis
0.14%
1/694
0.14%
1/697
Infections and infestations
Empyema
0.14%
1/694
0.00%
0/697
Infections and infestations
Epiglottitis
0.00%
0/694
0.14%
1/697
Infections and infestations
Gastrointestinal Infection
0.14%
1/694
0.00%
0/697
Infections and infestations
Infective Exacerbation Of Chronic Obstructive Airways Disease
0.00%
0/694
0.14%
1/697
Infections and infestations
Infective Myositis
0.14%
1/694
0.00%
0/697
Infections and infestations
Lobar Pneumonia
0.14%
1/694
0.00%
0/697
Infections and infestations
Lung Abscess
0.14%
1/694
0.14%
1/697
Infections and infestations
Oesophageal Candidiasis
0.14%
1/694
0.00%
0/697
Infections and infestations
Perianal Abscess
0.00%
0/694
0.14%
1/697
Infections and infestations
Pneumocystis Jiroveci Pneumonia
0.14%
1/694
0.00%
0/697
Infections and infestations
Pneumonia Streptococcal
0.00%
0/694
0.14%
1/697
Infections and infestations
Pyothorax
0.14%
1/694
0.00%
0/697
Infections and infestations
Rash Pustular
0.14%
1/694
0.00%
0/697
Infections and infestations
Rectal Abscess
0.14%
1/694
0.00%
0/697
Infections and infestations
Respiratory Tract Infection Bacterial
0.00%
0/694
0.14%
1/697
Infections and infestations
Skin Bacterial Infection
0.14%
1/694
0.00%
0/697
Infections and infestations
Staphylococcal Infection
0.14%
1/694
0.00%
0/697
Infections and infestations
Tuberculosis
0.14%
1/694
0.00%
0/697
Injury, poisoning and procedural complications
Femur Fracture
0.29%
2/694
0.14%
1/697
Injury, poisoning and procedural complications
Humerus Fracture
0.00%
0/694
0.29%
2/697
Injury, poisoning and procedural complications
Brain Contusion
0.00%
0/694
0.14%
1/697
Injury, poisoning and procedural complications
Facial Bones Fracture
0.00%
0/694
0.14%
1/697
Injury, poisoning and procedural complications
Foot Fracture
0.14%
1/694
0.00%
0/697
Injury, poisoning and procedural complications
Hip Fracture
0.14%
1/694
0.00%
0/697
Injury, poisoning and procedural complications
Lower Limb Fracture
0.14%
1/694
0.00%
0/697
Injury, poisoning and procedural complications
Multiple Fractures
0.00%
0/694
0.14%
1/697
Injury, poisoning and procedural complications
Radiation Pneumonitis
0.14%
1/694
0.00%
0/697
Injury, poisoning and procedural complications
Skin Laceration
0.00%
0/694
0.14%
1/697
Injury, poisoning and procedural complications
Skull Fracture
0.00%
0/694
0.14%
1/697
Injury, poisoning and procedural complications
Weight Decreased
0.00%
0/694
0.29%
2/697
Injury, poisoning and procedural complications
White Blood Cell Count Decreased
0.00%
0/694
0.29%
2/697
Injury, poisoning and procedural complications
Alanine Aminotransferase Increased
0.00%
0/694
0.14%
1/697
Injury, poisoning and procedural complications
Aspartate Aminotransferase Increased
0.00%
0/694
0.14%
1/697
Injury, poisoning and procedural complications
Blood Alkaline Phosphatase Increased
0.00%
0/694
0.14%
1/697
Injury, poisoning and procedural complications
Blood Pressure Orthostatic Decreased
0.14%
1/694
0.00%
0/697
Injury, poisoning and procedural complications
Electrocardiogram T Wave Abnormal
0.14%
1/694
0.00%
0/697
Injury, poisoning and procedural complications
Neutrophil Count Decreased
0.00%
0/694
0.14%
1/697
Metabolism and nutrition disorders
Anorexia
0.43%
3/694
0.29%
2/697
Metabolism and nutrition disorders
Dehydration
0.14%
1/694
0.43%
3/697
Metabolism and nutrition disorders
Hyperkalaemia
0.14%
1/694
0.29%
2/697
Metabolism and nutrition disorders
Hypoglycaemia
0.29%
2/694
0.29%
2/697
Metabolism and nutrition disorders
Hyponatraemia
0.14%
1/694
0.29%
2/697
Metabolism and nutrition disorders
Diabetes Mellitus
0.14%
1/694
0.00%
0/697
Metabolism and nutrition disorders
Failure To Thrive
0.14%
1/694
0.00%
0/697
Metabolism and nutrition disorders
Hypercalcaemia
0.14%
1/694
0.14%
1/697
Metabolism and nutrition disorders
Hyperglycaemia
0.14%
1/694
0.14%
1/697
Metabolism and nutrition disorders
Hypokalaemia
0.14%
1/694
0.00%
0/697
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
0.00%
0/694
0.14%
1/697
Musculoskeletal and connective tissue disorders
Back Pain
0.29%
2/694
0.57%
4/697
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
0.43%
3/694
0.57%
4/697
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/694
0.14%
1/697
Musculoskeletal and connective tissue disorders
Bone Pain
0.14%
1/694
0.14%
1/697
Musculoskeletal and connective tissue disorders
Flank Pain
0.00%
0/694
0.14%
1/697
Musculoskeletal and connective tissue disorders
Muscular Weakness
0.14%
1/694
0.14%
1/697
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
0.00%
0/694
0.14%
1/697
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/694
0.14%
1/697
Musculoskeletal and connective tissue disorders
Pain In Extremity
0.14%
1/694
0.14%
1/697
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
0.29%
2/694
0.29%
2/697
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pain
0.14%
1/694
0.00%
0/697
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
0.14%
1/694
0.00%
0/697
Nervous system disorders
Convulsion
0.58%
4/694
0.14%
1/697
Nervous system disorders
Dizziness
0.43%
3/694
0.57%
4/697
Nervous system disorders
Headache
0.14%
1/694
0.43%
3/697
Nervous system disorders
Loss Of Consciousness
0.43%
3/694
0.14%
1/697
Nervous system disorders
Somnolence
0.00%
0/694
0.29%
2/697
Nervous system disorders
Syncope
0.29%
2/694
0.29%
2/697
Nervous system disorders
Altered State Of Consciousness
0.14%
1/694
0.00%
0/697
Nervous system disorders
Ataxia
0.00%
0/694
0.14%
1/697
Nervous system disorders
Brachial Plexopathy
0.00%
0/694
0.14%
1/697
Nervous system disorders
Cauda Equina Syndrome
0.00%
0/694
0.14%
1/697
Nervous system disorders
Cerebral Haemorrhage
0.00%
0/694
0.14%
1/697
Nervous system disorders
Cerebral Infarction
0.14%
1/694
0.00%
0/697
Nervous system disorders
Cerebral Ischaemia
0.14%
1/694
0.14%
1/697
Nervous system disorders
Cerebrovascular Accident
0.14%
1/694
0.14%
1/697
Nervous system disorders
Coma
0.00%
0/694
0.14%
1/697
Nervous system disorders
Coma Hepatic
0.00%
0/694
0.14%
1/697
Nervous system disorders
Dyskinesia
0.00%
0/694
0.14%
1/697
Nervous system disorders
Hemiparesis
0.14%
1/694
0.00%
0/697
Nervous system disorders
Ischaemic Stroke
0.14%
1/694
0.00%
0/697
Nervous system disorders
Paraplegia
0.00%
0/694
0.14%
1/697
Nervous system disorders
Peripheral Sensory Neuropathy
0.14%
1/694
0.00%
0/697
Nervous system disorders
Polyneuropathy
0.14%
1/694
0.00%
0/697
Nervous system disorders
Pyramidal Tract Syndrome
0.00%
0/694
0.14%
1/697
Nervous system disorders
Spinal Cord Compression
0.14%
1/694
0.00%
0/697
Nervous system disorders
Subarachnoid Haemorrhage
0.00%
0/694
0.14%
1/697
Psychiatric disorders
Mental Status Changes
0.29%
2/694
0.14%
1/697
Psychiatric disorders
Anxiety
0.00%
0/694
0.14%
1/697
Psychiatric disorders
Confusional State
0.14%
1/694
0.00%
0/697
Psychiatric disorders
Delirium
0.00%
0/694
0.14%
1/697
Psychiatric disorders
Psychotic Behaviour
0.14%
1/694
0.00%
0/697
Psychiatric disorders
Suicidal Ideation
0.00%
0/694
0.14%
1/697
Renal and urinary disorders
Dysuria
0.00%
0/694
0.29%
2/697
Renal and urinary disorders
Renal Failure
0.29%
2/694
0.14%
1/697
Renal and urinary disorders
Haematuria
0.14%
1/694
0.00%
0/697
Renal and urinary disorders
Nephrolithiasis
0.00%
0/694
0.14%
1/697
Renal and urinary disorders
Renal Failure Acute
0.14%
1/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Dyspnoea
3.2%
22/694
3.0%
21/697
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
1.7%
12/694
0.86%
6/697
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.29%
2/694
1.1%
8/697
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.72%
5/694
0.86%
6/697
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.72%
5/694
0.86%
6/697
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.58%
4/694
0.72%
5/697
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.14%
1/694
0.72%
5/697
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.58%
4/694
0.43%
3/697
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
0.00%
0/694
0.43%
3/697
Respiratory, thoracic and mediastinal disorders
Cough
0.43%
3/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Aspiration
0.29%
2/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/694
0.29%
2/697
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.29%
2/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
0.14%
1/694
0.29%
2/697
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
0.14%
1/694
0.29%
2/697
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
0.14%
1/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.14%
1/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Cryptogenic Organising Pneumonia
0.14%
1/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Diaphragmatic Rupture
0.00%
0/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
0.00%
0/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
0.14%
1/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
0.14%
1/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
0.00%
0/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.00%
0/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
0.14%
1/694
0.00%
0/697
Respiratory, thoracic and mediastinal disorders
Productive Cough
0.00%
0/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Pulmonary Alveolar Haemorrhage
0.00%
0/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
0.00%
0/694
0.14%
1/697
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
0.14%
1/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Rash
2.2%
15/694
0.14%
1/697
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
0.72%
5/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Toxic Epidermal Necrolysis
0.58%
4/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative
0.43%
3/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
0.43%
3/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Drug Eruption
0.29%
2/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Erythema
0.29%
2/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Pruritus
0.29%
2/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Rash Erythematous
0.29%
2/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Toxic Skin Eruption
0.29%
2/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Dermatitis
0.14%
1/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Erythema Multiforme
0.14%
1/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Exfoliative Rash
0.14%
1/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
0.14%
1/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
0.14%
1/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Skin Toxicity
0.14%
1/694
0.00%
0/697
Skin and subcutaneous tissue disorders
Telangiectasia
0.14%
1/694
0.00%
0/697
Vascular disorders
Deep Vein Thrombosis
0.14%
1/694
0.86%
6/697
Vascular disorders
Hypotension
0.72%
5/694
0.14%
1/697
Vascular disorders
Peripheral Arterial Occlusive Disease
0.14%
1/694
0.00%
0/697
Vascular disorders
Peripheral Ischaemia
0.14%
1/694
0.00%
0/697
Vascular disorders
Shock
0.00%
0/694
0.14%
1/697
Vascular disorders
Subclavian Vein Thrombosis
0.14%
1/694
0.00%
0/697
Vascular disorders
Superior Vena Caval Stenosis
0.14%
1/694
0.00%
0/697
Vascular disorders
Vasculitis
0.00%
0/694
0.14%
1/697
Vascular disorders
Vena Cava Thrombosis
0.00%
0/694
0.14%
1/697
Vascular disorders
Venous Thrombosis
0.14%
1/694
0.00%
0/697

Other adverse events

Other adverse events
Measure
Vandetanib 100 mg Plus Docetaxel
n=694 participants at risk
Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel
n=697 participants at risk
Placebo plus docetaxel
Blood and lymphatic system disorders
Neutropenia
30.5%
212/694
25.0%
174/697
Blood and lymphatic system disorders
Leukopenia
18.0%
125/694
15.2%
106/697
Blood and lymphatic system disorders
Anaemia
9.8%
68/694
14.1%
98/697
Gastrointestinal disorders
Diarrhoea
40.9%
284/694
31.3%
218/697
Gastrointestinal disorders
Nausea
22.8%
158/694
31.7%
221/697
Gastrointestinal disorders
Vomiting
15.1%
105/694
20.2%
141/697
Gastrointestinal disorders
Constipation
17.1%
119/694
20.1%
140/697
Gastrointestinal disorders
Stomatitis
11.5%
80/694
11.5%
80/697
Gastrointestinal disorders
Abdominal Pain
5.9%
41/694
7.2%
50/697
Gastrointestinal disorders
Dyspepsia
5.3%
37/694
3.6%
25/697
Gastrointestinal disorders
Abdominal Pain Upper
4.3%
30/694
5.2%
36/697
General disorders
Fatigue
30.0%
208/694
30.7%
214/697
General disorders
Pyrexia
18.3%
127/694
15.8%
110/697
General disorders
Asthenia
15.1%
105/694
12.9%
90/697
General disorders
Oedema Peripheral
7.1%
49/694
8.2%
57/697
General disorders
Mucosal Inflammation
7.1%
49/694
5.5%
38/697
Infections and infestations
Nasopharyngitis
5.9%
41/694
5.3%
37/697
Infections and infestations
Weight Decreased
7.8%
54/694
5.9%
41/697
Metabolism and nutrition disorders
Anorexia
28.7%
199/694
29.3%
204/697
Musculoskeletal and connective tissue disorders
Myalgia
13.0%
90/694
11.2%
78/697
Musculoskeletal and connective tissue disorders
Back Pain
7.3%
51/694
8.9%
62/697
Musculoskeletal and connective tissue disorders
Arthralgia
8.8%
61/694
7.5%
52/697
Musculoskeletal and connective tissue disorders
Pain In Extremity
5.6%
39/694
4.4%
31/697
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
5.0%
35/694
4.3%
30/697
Nervous system disorders
Headache
8.4%
58/694
8.9%
62/697
Nervous system disorders
Dizziness
6.2%
43/694
8.3%
58/697
Nervous system disorders
Dysgeusia
5.8%
40/694
7.0%
49/697
Nervous system disorders
Peripheral Sensory Neuropathy
6.1%
42/694
6.9%
48/697
Nervous system disorders
Paraesthesia
6.1%
42/694
6.0%
42/697
Psychiatric disorders
Insomnia
13.7%
95/694
10.5%
73/697
Respiratory, thoracic and mediastinal disorders
Cough
18.7%
130/694
19.1%
133/697
Respiratory, thoracic and mediastinal disorders
Dyspnoea
14.7%
102/694
17.5%
122/697
Respiratory, thoracic and mediastinal disorders
Epistaxis
7.2%
50/694
3.9%
27/697
Respiratory, thoracic and mediastinal disorders
Haemoptysis
5.3%
37/694
6.5%
45/697
Respiratory, thoracic and mediastinal disorders
Dysphonia
5.9%
41/694
2.9%
20/697
Respiratory, thoracic and mediastinal disorders
Hiccups
4.3%
30/694
5.9%
41/697
Skin and subcutaneous tissue disorders
Rash
40.6%
282/694
23.8%
166/697
Skin and subcutaneous tissue disorders
Alopecia
33.1%
230/694
34.4%
240/697
Skin and subcutaneous tissue disorders
Pruritus
9.4%
65/694
6.0%
42/697
Skin and subcutaneous tissue disorders
Nail Disorder
7.5%
52/694
6.6%
46/697
Skin and subcutaneous tissue disorders
Dry Skin
6.5%
45/694
4.3%
30/697
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
6.1%
42/694
0.14%
1/697
Vascular disorders
Hypertension
5.9%
41/694
1.9%
13/697

Additional Information

Trial Transparency Team

Sanofi

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER