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| ID | Type | Description | Link |
|---|---|---|---|
| C1034T08 | Other Identifier | Centocor, Inc. | |
| 2006-005766-39 | EudraCT Number |
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The purpose of this study is to assess the effects of intetumumab when given in combination with docetaxel and prednisone to participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body until it kills).
This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives) study of intetumumab in combination with docetaxel and prednisone for the first-line treatment of participants with metastatic hormone-refractory prostate cancer. There will be 2 study groups. One group will receive intetumumab in combination with docetaxel and prednisone (study treatment) and the other group will receive placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) matching to intetumumab in combination with docetaxel and prednisone (control treatment). The duration of treatment will be 6 months. Participants who respond to treatment with stable disease or better will receive extended treatment until disease progression (disease worsening) or for an additional 6 months, whichever occurs first. Treatment can be further continued with the sponsor's discretion after receiving 6 months of extended treatment, if participant response to the treatment (with stable disease, partial response, or complete response). Participants who have confirmed progressive disease while receiving study treatment may have their treatment unblinded (participants will know the name of drug which was given to them), if they wish to be considered for alternative treatment. Participants who were receiving the control treatment will be considered to have completed the study treatment, and will have the option to receive alternative treatment. Alternative treatment will either be intetumumab along with docetaxel and prednisone or intetumumab alone. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel + Prednisone + Placebo | Active Comparator | 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. |
|
| Docetaxel + Prednisone + Intetumumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. | Baseline up to 6 months after last dose of study treatment, assessed up to 551 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Overall Response (OR) | 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. |
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Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Prednisone | Drug | Prednisone 5 mg orally twice daily. |
|
| Intetumumab | Biological | Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks. |
|
|
| Placebo | Drug | Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks. |
|
| Baseline up to 6 months after last dose of study treatment, assessed up to 551 days |
| Number of Participants With Prostate Specific Antigen (PSA) Response | 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). | Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days |
| Overall Survival | 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. | Baseline until death (up to 887 days) |
| Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. | Baseline, Week 6, 7, 10 and 13 |
| Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. | Baseline, Week 6, 7, 10 and 13 |
| Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. | Baseline, Week 6, 7, 10 and 13 |
| Los Angeles |
| California |
| United States |
| San Bernardino | California | United States |
| Wichita | Kansas | United States |
| Shreveport | Louisiana | United States |
| Charleston | South Carolina | United States |
| North Charleston | South Carolina | United States |
| Graz | Austria |
| Vienna | Austria |
| Wels | Austria |
| Antwerp | Belgium |
| Brasschaat | Belgium |
| Brussels | Belgium |
| Haine-Saint-Paul, La Louviere | Belgium |
| Leuven | Belgium |
| Liÿge | Belgium |
| Ottignies | Belgium |
| Roeselare | Belgium |
| Tournai | Belgium |
| Wilrijk | Belgium |
| Aschaffenburg | Germany |
| Berlin | Germany |
| Cologne | Germany |
| Freiburg im Breisgau | Germany |
| Kirchheim | Germany |
| Marburg | Germany |
| München | Germany |
| Tübingen | Germany |
| Ahmedabad | India |
| Bangalore | India |
| Chennai | India |
| Mumbai | India |
| New Delhi | India |
| Pune | India |
| Apeldoorn | Netherlands |
| Leiden | Netherlands |
| Maastricht | Netherlands |
| Nijmegen | Netherlands |
| The Hague | Netherlands |
| Bydgoszcz | Poland |
| Gdansk | Poland |
| Inowrocław | Poland |
| Kościerzyna | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Moscow | Russia |
| Moscow Region | Russia |
| Saint Petersburg | Russia |
| St-Petersburg Leningrad | Russia |
| Voronezh | Russia |
| Yaroslavl | Russia |
| Yekaterinburg | Russia |
| Johannesburg Gauteng | South Africa |
| Pretoria | South Africa |
| Pretoria Gauteng | South Africa |
| Cambridge | United Kingdom |
| Leicester | United Kingdom |
| Lincoln | United Kingdom |
| London | United Kingdom |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel + Prednisone + Placebo | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 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. | Efficacy population included all participants randomly assigned to study treatment. | Posted | Median | 95% Confidence Interval | Days | Baseline up to 6 months after last dose of study treatment, assessed up to 551 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Best Overall Response (OR) | 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. | 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. | Posted | Number | Participants | Baseline up to 6 months after last dose of study treatment, assessed up to 551 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Prostate Specific Antigen (PSA) Response | 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). | 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. | Posted | Number | Participants | Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | 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. | Efficacy population included all participants randomly assigned to study treatment. | Posted | Median | 95% Confidence Interval | Days | Baseline until death (up to 887 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 6, 7, 10 and 13 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 6, 7, 10 and 13 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 6, 7, 10 and 13 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Docetaxel + Prednisone + Placebo | 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. | 23 | 65 | 59 | 65 | ||
| EG001 | 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. | 24 | 66 | 59 | 66 | ||
| EG002 | Docetaxel + Prednisone + Placebo/ Intetumumab | 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. | 1 | 2 | 2 | 2 | ||
| EG003 | Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab | 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. | 4 | 9 | 6 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Extravasation | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Pneumatic compression therapy | Surgical and medical procedures | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 12.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Keratoconjunctivitis sicca | Eye disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Moraxella infection | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Enzyme abnormality | Metabolism and nutrition disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 12.1 | Non-systematic Assessment |
|
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.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen Research & Development, L.L.C. | 908-927-2116 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D011241 | Prednisone |
| C486839 | intetumumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| BELGIUM |
|
| GERMANY |
|
| INDIA |
|
| NETHERLANDS |
|
| POLAND |
|
| RUSSIAN FEDERATION |
|
| SOUTH AFRICA |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
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. |
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| Units | Counts |
|---|
| Participants |
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