Trial Outcomes & Findings for E3-Hormone Refractory Prostrate Cancer Taxotere Combination (NCT NCT00498797)
NCT ID: NCT00498797
Last Updated: 2016-10-07
Results Overview
Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline
Results posted on
2016-10-07
Participant Flow
First patient randomised 24 January 2006, last patient randomised 24 Nov 2006, data cut off data 21 July 2007
Participant milestones
| Measure |
Vandetanib
docetaxel/prednisolone/vandetanib
|
Placebo
docetaxel/prednisolone/placebo
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
COMPLETED
|
5
|
14
|
|
Overall Study
NOT COMPLETED
|
38
|
29
|
Reasons for withdrawal
| Measure |
Vandetanib
docetaxel/prednisolone/vandetanib
|
Placebo
docetaxel/prednisolone/placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Adverse Event
|
12
|
5
|
|
Overall Study
Condition under investigation worsened
|
19
|
21
|
|
Overall Study
Other
|
3
|
1
|
Baseline Characteristics
E3-Hormone Refractory Prostrate Cancer Taxotere Combination
Baseline characteristics by cohort
| Measure |
Vandetanib
n=43 Participants
docetaxel/prednisolone/vandetanib
|
Placebo
n=43 Participants
docetaxel/prednisolone/placebo
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=99 Participants
|
67 years
n=107 Participants
|
67 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baselineProstate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response
Outcome measures
| Measure |
Vandetanib
n=43 Participants
docetaxel/prednisolone/vandetanib
|
Placebo
n=43 Participants
docetaxel/prednisolone/placebo
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Response
|
17 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 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 (21 July 2007 or up to 7 days in advance of DCO)Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Outcome measures
| Measure |
Vandetanib
n=43 Participants
docetaxel/prednisolone/vandetanib
|
Placebo
n=43 Participants
docetaxel/prednisolone/placebo
|
|---|---|---|
|
Number of Patients With an Objective Disease Progression Event
|
28 Participants
|
26 Participants
|
Adverse Events
Vandetanib
Serious events: 23 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 15 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib
n=43 participants at risk
docetaxel/prednisolone/vandetanib
|
Placebo
n=43 participants at risk
docetaxel/prednisolone/placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
4.7%
2/43
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/43
|
2.3%
1/43
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.3%
1/43
|
0.00%
0/43
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.3%
1/43
|
2.3%
1/43
|
|
Eye disorders
BLINDNESS
|
2.3%
1/43
|
0.00%
0/43
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/43
|
2.3%
1/43
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/43
|
2.3%
1/43
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.00%
0/43
|
2.3%
1/43
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
2.3%
1/43
|
0.00%
0/43
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
2.3%
1/43
|
0.00%
0/43
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/43
|
2.3%
1/43
|
|
Gastrointestinal disorders
VOMITING
|
2.3%
1/43
|
2.3%
1/43
|
|
General disorders
FATIGUE
|
0.00%
0/43
|
2.3%
1/43
|
|
General disorders
PYREXIA
|
0.00%
0/43
|
2.3%
1/43
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
2.3%
1/43
|
0.00%
0/43
|
|
Infections and infestations
PNEUMONIA
|
7.0%
3/43
|
2.3%
1/43
|
|
Infections and infestations
DIVERTICULITIS
|
2.3%
1/43
|
0.00%
0/43
|
|
Infections and infestations
LOBAR PNEUMONIA
|
2.3%
1/43
|
0.00%
0/43
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
2.3%
1/43
|
0.00%
0/43
|
|
Infections and infestations
SEPSIS
|
2.3%
1/43
|
0.00%
0/43
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/43
|
2.3%
1/43
|
|
Injury, poisoning and procedural complications
STERNAL FRACTURE
|
0.00%
0/43
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
2.3%
1/43
|
0.00%
0/43
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.3%
1/43
|
2.3%
1/43
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
2.3%
1/43
|
0.00%
0/43
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
2.3%
1/43
|
0.00%
0/43
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
2.3%
1/43
|
0.00%
0/43
|
|
Nervous system disorders
EPILEPSY
|
2.3%
1/43
|
0.00%
0/43
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/43
|
2.3%
1/43
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/43
|
2.3%
1/43
|
|
Renal and urinary disorders
RENAL FAILURE
|
2.3%
1/43
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
4.7%
2/43
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.00%
0/43
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/43
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
2.3%
1/43
|
0.00%
0/43
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
2.3%
1/43
|
0.00%
0/43
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
2.3%
1/43
|
0.00%
0/43
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/43
|
2.3%
1/43
|
|
Vascular disorders
THROMBOPHLEBITIS
|
2.3%
1/43
|
0.00%
0/43
|
Other adverse events
| Measure |
Vandetanib
n=43 participants at risk
docetaxel/prednisolone/vandetanib
|
Placebo
n=43 participants at risk
docetaxel/prednisolone/placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.3%
1/43
|
11.6%
5/43
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
7.0%
3/43
|
9.3%
4/43
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
2.3%
1/43
|
7.0%
3/43
|
|
Cardiac disorders
PALPITATIONS
|
7.0%
3/43
|
0.00%
0/43
|
|
Ear and labyrinth disorders
VERTIGO
|
7.0%
3/43
|
2.3%
1/43
|
|
Eye disorders
LACRIMATION INCREASED
|
9.3%
4/43
|
16.3%
7/43
|
|
Eye disorders
CONJUNCTIVITIS
|
2.3%
1/43
|
7.0%
3/43
|
|
Gastrointestinal disorders
NAUSEA
|
16.3%
7/43
|
37.2%
16/43
|
|
Gastrointestinal disorders
DIARRHOEA
|
23.3%
10/43
|
30.2%
13/43
|
|
Gastrointestinal disorders
CONSTIPATION
|
9.3%
4/43
|
23.3%
10/43
|
|
Gastrointestinal disorders
VOMITING
|
2.3%
1/43
|
16.3%
7/43
|
|
Gastrointestinal disorders
STOMATITIS
|
9.3%
4/43
|
9.3%
4/43
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.3%
1/43
|
7.0%
3/43
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.0%
3/43
|
7.0%
3/43
|
|
General disorders
FATIGUE
|
37.2%
16/43
|
32.6%
14/43
|
|
General disorders
ASTHENIA
|
11.6%
5/43
|
16.3%
7/43
|
|
General disorders
OEDEMA PERIPHERAL
|
9.3%
4/43
|
16.3%
7/43
|
|
General disorders
PYREXIA
|
2.3%
1/43
|
9.3%
4/43
|
|
General disorders
CHILLS
|
7.0%
3/43
|
2.3%
1/43
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.3%
4/43
|
14.0%
6/43
|
|
Infections and infestations
URINARY TRACT INFECTION
|
11.6%
5/43
|
7.0%
3/43
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/43
|
7.0%
3/43
|
|
Metabolism and nutrition disorders
ANOREXIA
|
9.3%
4/43
|
7.0%
3/43
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.6%
5/43
|
14.0%
6/43
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.3%
1/43
|
11.6%
5/43
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.0%
3/43
|
9.3%
4/43
|
|
Nervous system disorders
DYSGEUSIA
|
18.6%
8/43
|
11.6%
5/43
|
|
Nervous system disorders
HEADACHE
|
2.3%
1/43
|
11.6%
5/43
|
|
Nervous system disorders
DIZZINESS
|
7.0%
3/43
|
7.0%
3/43
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/43
|
7.0%
3/43
|
|
Nervous system disorders
PARAESTHESIA
|
2.3%
1/43
|
7.0%
3/43
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
7.0%
3/43
|
4.7%
2/43
|
|
Psychiatric disorders
INSOMNIA
|
18.6%
8/43
|
16.3%
7/43
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.3%
1/43
|
14.0%
6/43
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
9.3%
4/43
|
9.3%
4/43
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
9.3%
4/43
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
7.0%
3/43
|
2.3%
1/43
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
2.3%
1/43
|
7.0%
3/43
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
37.2%
16/43
|
44.2%
19/43
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
11.6%
5/43
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
9.3%
4/43
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
9.3%
4/43
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
ONYCHOMADESIS
|
7.0%
3/43
|
2.3%
1/43
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
7.0%
3/43
|
4.7%
2/43
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
7.0%
3/43
|
0.00%
0/43
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
7.0%
3/43
|
2.3%
1/43
|
|
Vascular disorders
HYPERTENSION
|
14.0%
6/43
|
2.3%
1/43
|
|
Vascular disorders
FLUSHING
|
7.0%
3/43
|
2.3%
1/43
|
Additional Information
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