Trial Outcomes & Findings for An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer (NCT NCT00537381)
NCT ID: NCT00537381
Last Updated: 2013-06-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Results posted on
2013-06-20
Participant Flow
Participant milestones
| Measure |
Docetaxel + Prednisone + Placebo
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.
|
Docetaxel + Prednisone + Intetumumab
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 Study
STARTED
|
65
|
66
|
|
Overall Study
COMPLETED
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
56
|
62
|
Reasons for withdrawal
| Measure |
Docetaxel + Prednisone + Placebo
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.
|
Docetaxel + Prednisone + Intetumumab
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 Study
Adverse Event
|
13
|
9
|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
14
|
|
Overall Study
Physician Decision
|
7
|
6
|
|
Overall Study
Disease Progression
|
9
|
18
|
|
Overall Study
Sponsor decision
|
14
|
9
|
|
Overall Study
Other
|
5
|
3
|
Baseline Characteristics
An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel + Prednisone + Placebo
n=65 Participants
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.
|
Docetaxel + Prednisone + Intetumumab
n=66 Participants
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
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
67.2 Years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
66.3 Years
STANDARD_DEVIATION 7.51 • n=7 Participants
|
66.7 Years
STANDARD_DEVIATION 8.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Region of Enrollment
AUSTRIA
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
BELGIUM
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
GERMANY
|
19 participants
n=5 Participants
|
14 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
INDIA
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
NETHERLANDS
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
POLAND
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 6 months after last dose of study treatment, assessed up to 551 daysPopulation: Efficacy population included all participants randomly assigned to study treatment.
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.
Outcome measures
| Measure |
Docetaxel + Prednisone + Placebo
n=65 Participants
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.
|
Docetaxel + Prednisone + Intetumumab
n=66 Participants
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.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
336.0 Days
Interval 266.0 to 477.0
|
232.0 Days
Interval 155.0 to 320.0
|
SECONDARY outcome
Timeframe: Baseline up to 6 months after last dose of study treatment, assessed up to 551 daysPopulation: 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.
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.
Outcome measures
| Measure |
Docetaxel + Prednisone + Placebo
n=50 Participants
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.
|
Docetaxel + Prednisone + Intetumumab
n=50 Participants
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.
|
|---|---|---|
|
Number of Participants With Best Overall Response (OR)
Complete Response
|
1 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response (OR)
Partial Response
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 daysPopulation: 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.
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).
Outcome measures
| Measure |
Docetaxel + Prednisone + Placebo
n=63 Participants
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.
|
Docetaxel + Prednisone + Intetumumab
n=58 Participants
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.
|
|---|---|---|
|
Number of Participants With Prostate Specific Antigen (PSA) Response
|
43 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline until death (up to 887 days)Population: Efficacy population included all participants randomly assigned to study treatment.
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.
Outcome measures
| Measure |
Docetaxel + Prednisone + Placebo
n=65 Participants
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.
|
Docetaxel + Prednisone + Intetumumab
n=66 Participants
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 Survival
|
626.0 Days
Interval 532.0 to
Upper limit of confidence interval was not estimable due to the high number of participants censored for survival.
|
522.0 Days
Interval 418.0 to
Upper limit of confidence interval was not estimable due to the high number of participants censored for survival.
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 7, 10 and 13Population: 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.
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Outcome measures
| Measure |
Docetaxel + Prednisone + Placebo
n=11 Participants
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.
|
Docetaxel + Prednisone + Intetumumab
n=65 Participants
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.
|
|---|---|---|
|
Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Percent Change at Week 6 (n = 10, 48)
|
1.45 Percent change
Standard Deviation 51.019
|
-30.81 Percent change
Standard Deviation 42.091
|
|
Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Percent Change at Week 7 (n = 10, 54)
|
-11.58 Percent change
Standard Deviation 45.396
|
-39.78 Percent change
Standard Deviation 32.437
|
|
Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Percent Change at Week 10 (n = 11, 51)
|
2.39 Percent change
Standard Deviation 53.537
|
-25.48 Percent change
Standard Deviation 122.178
|
|
Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Percent Change at Week 13 (n = 11, 41)
|
5.22 Percent change
Standard Deviation 59.728
|
-44.89 Percent change
Standard Deviation 40.941
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 7, 10 and 13Population: 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.
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Outcome measures
| Measure |
Docetaxel + Prednisone + Placebo
n=11 Participants
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.
|
Docetaxel + Prednisone + Intetumumab
n=65 Participants
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.
|
|---|---|---|
|
Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Percent Change at Week 6 (n = 10, 48)
|
-0.77 Percent change
Standard Deviation 37.584
|
-21.37 Percent change
Standard Deviation 47.747
|
|
Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Percent Change at Week 7 (n = 10, 54)
|
1.58 Percent change
Standard Deviation 40.651
|
-23.44 Percent change
Standard Deviation 34.703
|
|
Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Percent Change at Week 10 (n = 11, 51)
|
2.55 Percent change
Standard Deviation 46.433
|
-21.71 Percent change
Standard Deviation 63.890
|
|
Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Percent Change at Week 13 (n = 11, 40)
|
-3.87 Percent change
Standard Deviation 31.845
|
-36.47 Percent change
Standard Deviation 25.701
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 7, 10 and 13Population: 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.
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Outcome measures
| Measure |
Docetaxel + Prednisone + Placebo
n=11 Participants
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.
|
Docetaxel + Prednisone + Intetumumab
n=65 Participants
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.
|
|---|---|---|
|
Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
Percent Change at Week 6 (n = 10, 48)
|
-10.00 Percent change
Standard Deviation 29.609
|
-9.64 Percent change
Standard Deviation 34.229
|
|
Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
Percent Change at Week 7 (n = 10, 54)
|
-3.10 Percent change
Standard Deviation 24.465
|
11.69 Percent change
Standard Deviation 41.338
|
|
Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
Percent Change at Week 10 (n = 11, 51)
|
3.96 Percent change
Standard Deviation 27.859
|
32.11 Percent change
Standard Deviation 85.953
|
|
Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
Percent Change at Week 13 (n = 11, 41)
|
8.22 Percent change
Standard Deviation 32.622
|
20.19 Percent change
Standard Deviation 55.565
|
Adverse Events
Docetaxel + Prednisone + Placebo
Serious events: 23 serious events
Other events: 59 other events
Deaths: 0 deaths
Docetaxel + Prednisone + Intetumumab
Serious events: 24 serious events
Other events: 59 other events
Deaths: 0 deaths
Docetaxel + Prednisone + Placebo/ Intetumumab
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel + Prednisone + Placebo
n=65 participants at risk
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.
|
Docetaxel + Prednisone + Intetumumab
n=66 participants at risk
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.
|
Docetaxel + Prednisone + Placebo/ Intetumumab
n=2 participants at risk
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.
|
Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab
n=9 participants at risk
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
2/65
|
3.0%
2/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
2/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/65
|
4.5%
3/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
2/65
|
3.0%
2/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Cardiac disorders
Cardiac failure
|
1.5%
1/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/65
|
4.5%
3/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/65
|
3.0%
2/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/65
|
0.00%
0/66
|
50.0%
1/2
|
0.00%
0/9
|
|
General disorders
Asthenia
|
3.1%
2/65
|
4.5%
3/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
Death
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
Disease progression
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
General disorders
Extravasation
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
General physical health deterioration
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
Oedema
|
1.5%
1/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
Pyrexia
|
4.6%
3/65
|
1.5%
1/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Cellulitis
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Necrotising fasciitis
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Perirectal abscess
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Sepsis
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/65
|
0.00%
0/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Infections and infestations
Systemic candida
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Investigations
Coagulation time prolonged
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Investigations
Weight decreased
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/65
|
0.00%
0/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Dizziness
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Paralysis
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/65
|
4.5%
3/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Syncope
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Renal and urinary disorders
Haematuria
|
3.1%
2/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Renal and urinary disorders
Renal failure acute
|
1.5%
1/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
2/65
|
1.5%
1/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.1%
2/65
|
3.0%
2/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Surgical and medical procedures
Pneumatic compression therapy
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Vascular disorders
Aneurysm
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Vascular disorders
Hypotension
|
3.1%
2/65
|
0.00%
0/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Vascular disorders
Thrombosis
|
0.00%
0/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
Other adverse events
| Measure |
Docetaxel + Prednisone + Placebo
n=65 participants at risk
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.
|
Docetaxel + Prednisone + Intetumumab
n=66 participants at risk
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.
|
Docetaxel + Prednisone + Placebo/ Intetumumab
n=2 participants at risk
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.
|
Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab
n=9 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.5%
12/65
|
13.6%
9/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.8%
22/65
|
24.2%
16/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.3%
21/65
|
21.2%
14/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Eye disorders
Dry eye
|
6.2%
4/65
|
4.5%
3/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Eye disorders
Keratoconjunctivitis sicca
|
7.7%
5/65
|
3.0%
2/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Eye disorders
Lacrimation increased
|
12.3%
8/65
|
10.6%
7/66
|
0.00%
0/2
|
22.2%
2/9
|
|
Eye disorders
Ocular hyperaemia
|
1.5%
1/65
|
6.1%
4/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Eye disorders
Ocular hypertension
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Eye disorders
Photophobia
|
0.00%
0/65
|
6.1%
4/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Eye disorders
Vision blurred
|
6.2%
4/65
|
4.5%
3/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
2/65
|
3.0%
2/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Gastrointestinal disorders
Constipation
|
20.0%
13/65
|
13.6%
9/66
|
50.0%
1/2
|
22.2%
2/9
|
|
Gastrointestinal disorders
Diarrhoea
|
33.8%
22/65
|
27.3%
18/66
|
0.00%
0/2
|
22.2%
2/9
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
4/65
|
4.5%
3/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
26.2%
17/65
|
27.3%
18/66
|
50.0%
1/2
|
33.3%
3/9
|
|
Gastrointestinal disorders
Oesophagitis
|
1.5%
1/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Gastrointestinal disorders
Stomatitis
|
13.8%
9/65
|
4.5%
3/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
10/65
|
9.1%
6/66
|
50.0%
1/2
|
0.00%
0/9
|
|
General disorders
Asthenia
|
24.6%
16/65
|
22.7%
15/66
|
50.0%
1/2
|
0.00%
0/9
|
|
General disorders
Fatigue
|
26.2%
17/65
|
25.8%
17/66
|
0.00%
0/2
|
22.2%
2/9
|
|
General disorders
Hypothermia
|
6.2%
4/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
Mucosal inflammation
|
6.2%
4/65
|
3.0%
2/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
Oedema peripheral
|
10.8%
7/65
|
12.1%
8/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
Pain
|
7.7%
5/65
|
1.5%
1/66
|
0.00%
0/2
|
0.00%
0/9
|
|
General disorders
Pyrexia
|
15.4%
10/65
|
19.7%
13/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
9.2%
6/65
|
4.5%
3/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65
|
0.00%
0/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Infections and infestations
Moraxella infection
|
0.00%
0/65
|
0.00%
0/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
4/65
|
7.6%
5/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Infections and infestations
Rhinitis
|
1.5%
1/65
|
0.00%
0/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Infections and infestations
Urinary tract infection
|
7.7%
5/65
|
3.0%
2/66
|
50.0%
1/2
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
13/65
|
13.6%
9/66
|
50.0%
1/2
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Enzyme abnormality
|
6.2%
4/65
|
7.6%
5/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.8%
9/65
|
13.6%
9/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
7/65
|
7.6%
5/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
9/65
|
6.1%
4/66
|
50.0%
1/2
|
22.2%
2/9
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.2%
6/65
|
4.5%
3/66
|
50.0%
1/2
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.6%
3/65
|
7.6%
5/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.3%
8/65
|
4.5%
3/66
|
0.00%
0/2
|
22.2%
2/9
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.8%
7/65
|
10.6%
7/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.5%
1/65
|
1.5%
1/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Nervous system disorders
Dizziness
|
10.8%
7/65
|
9.1%
6/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Dysgeusia
|
23.1%
15/65
|
19.7%
13/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Nervous system disorders
Headache
|
13.8%
9/65
|
19.7%
13/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Neuropathy peripheral
|
6.2%
4/65
|
3.0%
2/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Nervous system disorders
Paraesthesia
|
15.4%
10/65
|
16.7%
11/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Nervous system disorders
Paresis
|
0.00%
0/65
|
0.00%
0/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.9%
11/65
|
13.6%
9/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Psychiatric disorders
Depression
|
0.00%
0/65
|
1.5%
1/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Psychiatric disorders
Insomnia
|
3.1%
2/65
|
10.6%
7/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Renal and urinary disorders
Haematuria
|
6.2%
4/65
|
12.1%
8/66
|
50.0%
1/2
|
22.2%
2/9
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
4/65
|
1.5%
1/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
3/65
|
6.1%
4/66
|
50.0%
1/2
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
5/65
|
6.1%
4/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.3%
8/65
|
13.6%
9/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/65
|
0.00%
0/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.1%
28/65
|
25.8%
17/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
1/65
|
3.0%
2/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.8%
9/65
|
10.6%
7/66
|
50.0%
1/2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
18.5%
12/65
|
10.6%
7/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/2
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.2%
6/65
|
4.5%
3/66
|
0.00%
0/2
|
0.00%
0/9
|
|
Vascular disorders
Hypertension
|
7.7%
5/65
|
3.0%
2/66
|
0.00%
0/2
|
0.00%
0/9
|
Additional Information
Senior Director
Janssen Research & Development, L.L.C.
Phone: 908-927-2116
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60