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An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00537381
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : May 20, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostatic Neoplasms
Interventions Drug: Docetaxel
Drug: Prednisone
Biological: Intetumumab
Drug: Placebo
Enrollment 131
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab
Hide Arm/Group Description Matching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone. Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Period Title: Overall Study
Started 65 [1] 66
Completed 9 4
Not Completed 56 62
Reason Not Completed
Adverse Event             13             9
Death             3             3
Withdrawal by Subject             5             14
Physician Decision             7             6
Disease Progression             9             18
Sponsor decision             14             9
Other             5             3
[1]
11 Participants after disease progression switched to intetumumab alone (2) or D+P+ Intetumumab (9).
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab Total
Hide Arm/Group Description Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone. Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Total of all reporting groups
Overall Number of Baseline Participants 65 66 131
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 66 participants 131 participants
67.2  (8.74) 66.3  (7.51) 66.7  (8.13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
65
 100.0%
66
 100.0%
131
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
AUSTRIA 3 2 5
BELGIUM 10 9 19
GERMANY 19 14 33
INDIA 11 10 21
NETHERLANDS 2 5 7
POLAND 13 10 23
RUSSIAN FEDERATION 4 12 16
SOUTH AFRICA 1 0 1
UNITED KINGDOM 1 1 2
UNITED STATES 1 3 4
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Time Frame Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants randomly assigned to study treatment.
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab
Hide Arm/Group Description:
Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Overall Number of Participants Analyzed 65 66
Median (95% Confidence Interval)
Unit of Measure: Days
336.0
(266.0 to 477.0)
232.0
(155.0 to 320.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel + Prednisone + Placebo, Docetaxel + Prednisone + Intetumumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.728
Confidence Interval (2-Sided) 95%
1.112 to 2.686
Estimation Comments Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.
2.Secondary Outcome
Title Number of Participants With Best Overall Response (OR)
Hide Description Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
Time Frame Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Hide Outcome Measure Data
Hide Analysis Population Description
Response evaluable population included participants who had target lesion or non-target lesion at baseline and received at least 1 study treatment and had at least 1 post-baseline response assessment or discontinued study treatment due to disease progression, or death.
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab
Hide Arm/Group Description:
Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Participants
Complete Response 1 0
Partial Response 9 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel + Prednisone + Placebo, Docetaxel + Prednisone + Intetumumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.795
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Prostate Specific Antigen (PSA) Response
Hide Description The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later).
Time Frame Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days
Hide Outcome Measure Data
Hide Analysis Population Description
Included all participants randomly assigned to study treatment and had baseline PSA evaluation and at least two post-baseline evaluations that are at least 3 weeks apart.
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab
Hide Arm/Group Description:
Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Overall Number of Participants Analyzed 63 58
Measure Type: Number
Unit of Measure: Participants
43 27
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel + Prednisone + Placebo, Docetaxel + Prednisone + Intetumumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
Time Frame Baseline until death (up to 887 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population included all participants randomly assigned to study treatment.
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab
Hide Arm/Group Description:
Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Overall Number of Participants Analyzed 65 66
Median (95% Confidence Interval)
Unit of Measure: Days
626.0 [1] 
(532.0 to NA)
522.0 [1] 
(418.0 to NA)
[1]
Upper limit of confidence interval was not estimable due to the high number of participants censored for survival.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel + Prednisone + Placebo, Docetaxel + Prednisone + Intetumumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.163
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.476
Confidence Interval (2-Sided) 95%
0.853 to 2.522
Estimation Comments Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.
5.Secondary Outcome
Title Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Hide Description Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Time Frame Baseline, Week 6, 7, 10 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab
Hide Arm/Group Description:
Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Overall Number of Participants Analyzed 11 65
Mean (Standard Deviation)
Unit of Measure: Percent change
Percent Change at Week 6 (n = 10, 48) 1.45  (51.019) -30.81  (42.091)
Percent Change at Week 7 (n = 10, 54) -11.58  (45.396) -39.78  (32.437)
Percent Change at Week 10 (n = 11, 51) 2.39  (53.537) -25.48  (122.178)
Percent Change at Week 13 (n = 11, 41) 5.22  (59.728) -44.89  (40.941)
6.Secondary Outcome
Title Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Hide Description Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Time Frame Baseline, Week 6, 7, 10 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab
Hide Arm/Group Description:
Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Overall Number of Participants Analyzed 11 65
Mean (Standard Deviation)
Unit of Measure: Percent change
Percent Change at Week 6 (n = 10, 48) -0.77  (37.584) -21.37  (47.747)
Percent Change at Week 7 (n = 10, 54) 1.58  (40.651) -23.44  (34.703)
Percent Change at Week 10 (n = 11, 51) 2.55  (46.433) -21.71  (63.890)
Percent Change at Week 13 (n = 11, 40) -3.87  (31.845) -36.47  (25.701)
7.Secondary Outcome
Title Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
Hide Description Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Time Frame Baseline, Week 6, 7, 10 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab
Hide Arm/Group Description:
Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Overall Number of Participants Analyzed 11 65
Mean (Standard Deviation)
Unit of Measure: Percent change
Percent Change at Week 6 (n = 10, 48) -10.00  (29.609) -9.64  (34.229)
Percent Change at Week 7 (n = 10, 54) -3.10  (24.465) 11.69  (41.338)
Percent Change at Week 10 (n = 11, 51) 3.96  (27.859) 32.11  (85.953)
Percent Change at Week 13 (n = 11, 41) 8.22  (32.622) 20.19  (55.565)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab Docetaxel + Prednisone + Placebo/ Intetumumab Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab
Hide Arm/Group Description Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone. Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to intetumumab alone (2 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks till disease progression. Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to Docetaxel (D) + Prednisone (P) + intetumumab (9 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily till disease progression.
All-Cause Mortality
Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab Docetaxel + Prednisone + Placebo/ Intetumumab Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab Docetaxel + Prednisone + Placebo/ Intetumumab Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/65 (35.38%)   24/66 (36.36%)   1/2 (50.00%)   4/9 (44.44%) 
Blood and lymphatic system disorders         
Anaemia * 1  2/65 (3.08%)  2/66 (3.03%)  0/2 (0.00%)  0/9 (0.00%) 
Febrile neutropenia * 1  2/65 (3.08%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Haemorrhagic anaemia * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Leukopenia * 1  0/65 (0.00%)  3/66 (4.55%)  0/2 (0.00%)  0/9 (0.00%) 
Neutropenia * 1  2/65 (3.08%)  2/66 (3.03%)  0/2 (0.00%)  0/9 (0.00%) 
Cardiac disorders         
Atrial fibrillation * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Cardiac disorder * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Cardiac failure * 1  1/65 (1.54%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Ischaemic cardiomyopathy * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Myocardial infarction * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  1/65 (1.54%)  3/66 (4.55%)  0/2 (0.00%)  1/9 (11.11%) 
Diarrhoea * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Diverticular perforation * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Dysphagia * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Gastric ulcer * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Gastrointestinal haemorrhage * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Intestinal obstruction * 1  0/65 (0.00%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Intestinal perforation * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Peritonitis * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Stomatitis * 1  0/65 (0.00%)  2/66 (3.03%)  0/2 (0.00%)  0/9 (0.00%) 
Upper gastrointestinal haemorrhage * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Vomiting * 1  0/65 (0.00%)  0/66 (0.00%)  1/2 (50.00%)  0/9 (0.00%) 
General disorders         
Asthenia * 1  2/65 (3.08%)  3/66 (4.55%)  0/2 (0.00%)  0/9 (0.00%) 
Death * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Disease progression * 1  0/65 (0.00%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Extravasation * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
General physical health deterioration * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Oedema * 1  1/65 (1.54%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Pyrexia * 1  3/65 (4.62%)  1/66 (1.52%)  1/2 (50.00%)  0/9 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Jaundice * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Infections and infestations         
Bronchitis * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Cellulitis * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Necrotising fasciitis * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Oesophageal candidiasis * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Perirectal abscess * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Pneumonia * 1  1/65 (1.54%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Sepsis * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Staphylococcal infection * 1  0/65 (0.00%)  0/66 (0.00%)  1/2 (50.00%)  0/9 (0.00%) 
Systemic candida * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Upper respiratory tract infection * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Urinary tract infection bacterial * 1  0/65 (0.00%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications         
Alcohol poisoning * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Hip fracture * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Spinal cord injury * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Investigations         
Coagulation time prolonged * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Weight decreased * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/65 (0.00%)  0/66 (0.00%)  1/2 (50.00%)  0/9 (0.00%) 
Dehydration * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Hypercreatinaemia * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Pain in extremity * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Metastases to bone * 1  0/65 (0.00%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Nervous system disorders         
Balance disorder * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Dizziness * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Hypotonia * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Paraesthesia * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Paralysis * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Paraparesis * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Paraplegia * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Peripheral motor neuropathy * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Spinal cord compression * 1  0/65 (0.00%)  3/66 (4.55%)  0/2 (0.00%)  0/9 (0.00%) 
Syncope * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Renal and urinary disorders         
Haematuria * 1  2/65 (3.08%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Renal failure acute * 1  1/65 (1.54%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Urinary retention * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Cough * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Dyspnoea * 1  2/65 (3.08%)  1/66 (1.52%)  1/2 (50.00%)  0/9 (0.00%) 
Epistaxis * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Pulmonary embolism * 1  2/65 (3.08%)  2/66 (3.03%)  0/2 (0.00%)  0/9 (0.00%) 
Surgical and medical procedures         
Pneumatic compression therapy * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Vascular disorders         
Aneurysm * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Deep vein thrombosis * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Hypotension * 1  2/65 (3.08%)  0/66 (0.00%)  0/2 (0.00%)  0/9 (0.00%) 
Thrombosis * 1  0/65 (0.00%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Docetaxel + Prednisone + Placebo Docetaxel + Prednisone + Intetumumab Docetaxel + Prednisone + Placebo/ Intetumumab Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   59/65 (90.77%)   59/66 (89.39%)   2/2 (100.00%)   6/9 (66.67%) 
Blood and lymphatic system disorders         
Anaemia * 1  12/65 (18.46%)  9/66 (13.64%)  1/2 (50.00%)  0/9 (0.00%) 
Leukopenia * 1  22/65 (33.85%)  16/66 (24.24%)  0/2 (0.00%)  1/9 (11.11%) 
Neutropenia * 1  21/65 (32.31%)  14/66 (21.21%)  0/2 (0.00%)  1/9 (11.11%) 
Eye disorders         
Dry eye * 1  4/65 (6.15%)  3/66 (4.55%)  0/2 (0.00%)  0/9 (0.00%) 
Keratoconjunctivitis sicca * 1  5/65 (7.69%)  2/66 (3.03%)  0/2 (0.00%)  0/9 (0.00%) 
Lacrimation increased * 1  8/65 (12.31%)  7/66 (10.61%)  0/2 (0.00%)  2/9 (22.22%) 
Ocular hyperaemia * 1  1/65 (1.54%)  4/66 (6.06%)  0/2 (0.00%)  0/9 (0.00%) 
Ocular hypertension * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Photophobia * 1  0/65 (0.00%)  4/66 (6.06%)  0/2 (0.00%)  0/9 (0.00%) 
Vision blurred * 1  4/65 (6.15%)  3/66 (4.55%)  0/2 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  2/65 (3.08%)  2/66 (3.03%)  0/2 (0.00%)  1/9 (11.11%) 
Colitis * 1  0/65 (0.00%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Constipation * 1  13/65 (20.00%)  9/66 (13.64%)  1/2 (50.00%)  2/9 (22.22%) 
Diarrhoea * 1  22/65 (33.85%)  18/66 (27.27%)  0/2 (0.00%)  2/9 (22.22%) 
Gastritis * 1  4/65 (6.15%)  3/66 (4.55%)  0/2 (0.00%)  0/9 (0.00%) 
Nausea * 1  17/65 (26.15%)  18/66 (27.27%)  1/2 (50.00%)  3/9 (33.33%) 
Oesophagitis * 1  1/65 (1.54%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Stomatitis * 1  9/65 (13.85%)  3/66 (4.55%)  0/2 (0.00%)  0/9 (0.00%) 
Vomiting * 1  10/65 (15.38%)  6/66 (9.09%)  1/2 (50.00%)  0/9 (0.00%) 
General disorders         
Asthenia * 1  16/65 (24.62%)  15/66 (22.73%)  1/2 (50.00%)  0/9 (0.00%) 
Fatigue * 1  17/65 (26.15%)  17/66 (25.76%)  0/2 (0.00%)  2/9 (22.22%) 
Hypothermia * 1  4/65 (6.15%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Mucosal inflammation * 1  4/65 (6.15%)  2/66 (3.03%)  0/2 (0.00%)  0/9 (0.00%) 
Oedema peripheral * 1  7/65 (10.77%)  8/66 (12.12%)  0/2 (0.00%)  0/9 (0.00%) 
Pain * 1  5/65 (7.69%)  1/66 (1.52%)  0/2 (0.00%)  0/9 (0.00%) 
Pyrexia * 1  10/65 (15.38%)  13/66 (19.70%)  0/2 (0.00%)  0/9 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal * 1  6/65 (9.23%)  3/66 (4.55%)  0/2 (0.00%)  1/9 (11.11%) 
Infections and infestations         
Bronchitis * 1  1/65 (1.54%)  0/66 (0.00%)  1/2 (50.00%)  0/9 (0.00%) 
Moraxella infection * 1  0/65 (0.00%)  0/66 (0.00%)  1/2 (50.00%)  0/9 (0.00%) 
Nasopharyngitis * 1  4/65 (6.15%)  5/66 (7.58%)  0/2 (0.00%)  1/9 (11.11%) 
Rhinitis * 1  1/65 (1.54%)  0/66 (0.00%)  1/2 (50.00%)  0/9 (0.00%) 
Urinary tract infection * 1  5/65 (7.69%)  2/66 (3.03%)  1/2 (50.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  13/65 (20.00%)  9/66 (13.64%)  1/2 (50.00%)  1/9 (11.11%) 
Enzyme abnormality * 1  4/65 (6.15%)  5/66 (7.58%)  0/2 (0.00%)  0/9 (0.00%) 
Hyperglycaemia * 1  9/65 (13.85%)  9/66 (13.64%)  0/2 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  7/65 (10.77%)  5/66 (7.58%)  0/2 (0.00%)  1/9 (11.11%) 
Back pain * 1  9/65 (13.85%)  4/66 (6.06%)  1/2 (50.00%)  2/9 (22.22%) 
Bone pain * 1  6/65 (9.23%)  3/66 (4.55%)  1/2 (50.00%)  1/9 (11.11%) 
Musculoskeletal pain * 1  3/65 (4.62%)  5/66 (7.58%)  0/2 (0.00%)  0/9 (0.00%) 
Myalgia * 1  8/65 (12.31%)  3/66 (4.55%)  0/2 (0.00%)  2/9 (22.22%) 
Myositis * 1  0/65 (0.00%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Pain in extremity * 1  7/65 (10.77%)  7/66 (10.61%)  0/2 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cancer pain * 1  1/65 (1.54%)  1/66 (1.52%)  0/2 (0.00%)  1/9 (11.11%) 
Nervous system disorders         
Dizziness * 1  7/65 (10.77%)  6/66 (9.09%)  0/2 (0.00%)  0/9 (0.00%) 
Dysgeusia * 1  15/65 (23.08%)  13/66 (19.70%)  0/2 (0.00%)  1/9 (11.11%) 
Headache * 1  9/65 (13.85%)  13/66 (19.70%)  0/2 (0.00%)  0/9 (0.00%) 
Neuropathy peripheral * 1  4/65 (6.15%)  2/66 (3.03%)  0/2 (0.00%)  0/9 (0.00%) 
Paraesthesia * 1  10/65 (15.38%)  11/66 (16.67%)  0/2 (0.00%)  1/9 (11.11%) 
Paresis * 1  0/65 (0.00%)  0/66 (0.00%)  1/2 (50.00%)  0/9 (0.00%) 
Peripheral sensory neuropathy * 1  11/65 (16.92%)  9/66 (13.64%)  0/2 (0.00%)  0/9 (0.00%) 
Psychiatric disorders         
Depression * 1  0/65 (0.00%)  1/66 (1.52%)  1/2 (50.00%)  0/9 (0.00%) 
Insomnia * 1  2/65 (3.08%)  7/66 (10.61%)  1/2 (50.00%)  0/9 (0.00%) 
Renal and urinary disorders         
Haematuria * 1  4/65 (6.15%)  8/66 (12.12%)  1/2 (50.00%)  2/9 (22.22%) 
Proteinuria * 1  4/65 (6.15%)  1/66 (1.52%)  0/2 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  3/65 (4.62%)  4/66 (6.06%)  1/2 (50.00%)  1/9 (11.11%) 
Dyspnoea * 1  5/65 (7.69%)  4/66 (6.06%)  1/2 (50.00%)  0/9 (0.00%) 
Epistaxis * 1  8/65 (12.31%)  9/66 (13.64%)  0/2 (0.00%)  0/9 (0.00%) 
Sputum increased * 1  0/65 (0.00%)  0/66 (0.00%)  1/2 (50.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  28/65 (43.08%)  17/66 (25.76%)  0/2 (0.00%)  0/9 (0.00%) 
Dry skin * 1  1/65 (1.54%)  2/66 (3.03%)  1/2 (50.00%)  0/9 (0.00%) 
Erythema * 1  9/65 (13.85%)  7/66 (10.61%)  1/2 (50.00%)  0/9 (0.00%) 
Nail disorder * 1  12/65 (18.46%)  7/66 (10.61%)  0/2 (0.00%)  0/9 (0.00%) 
Onychomadesis * 1  0/65 (0.00%)  0/66 (0.00%)  0/2 (0.00%)  1/9 (11.11%) 
Rash * 1  6/65 (9.23%)  3/66 (4.55%)  0/2 (0.00%)  0/9 (0.00%) 
Vascular disorders         
Hypertension * 1  5/65 (7.69%)  2/66 (3.03%)  0/2 (0.00%)  0/9 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.1
Treatment with intetumumab/placebo was permanently discontinued after a planned, preliminary review of interim analysis data. Therefore, study treatment with intetumumab was not completed for some participants.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, L.L.C.
Phone: 908-927-2116
Layout table for additonal information
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00537381    
Other Study ID Numbers: CR013249
C1034T08 ( Other Identifier: Centocor, Inc. )
2006-005766-39 ( EudraCT Number )
First Submitted: September 27, 2007
First Posted: October 1, 2007
Results First Submitted: March 28, 2013
Results First Posted: May 20, 2013
Last Update Posted: June 20, 2013