Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C0328T07 | |||
| 2006-001671-38 | EudraCT Number |
Not provided
Not provided
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Prematurely stopped after Independent Data Monitoring Committee (IDMC) evaluation for lack of efficacy.
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The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in 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) (HRPC).
This is a 2-part, open-label (all people know the identity of the intervention) multicenter (when more than 1 hospital or medical school team work on a medical research study), Phase 2 study to evaluate the safety and efficacy of the combination of siltuximab plus mitoxantrone versus mitoxantrone in participants with metastatic HRPC who have received 1 prior Docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents) regimen (pattern of giving treatment). Part 1 of the study is single arm where participants will receive mitoxantrone, prednisone and siltuximab. Part 2 of the study is randomized portion (the study drug is assigned by chance), consisting of 2-arms. The experimental arm will consist of treatment with mitoxantrone, prednisone and siltuximab. The control arm will consist of treatment with mitoxantrone and prednisone. Mitoxantrone will be administered at a dose of 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle, until disease progression or unacceptable toxicity (any harmful effect of a drug) or up to 10 cycles (a maximum total dose of approximately 120 mg/m^2). Siltuximab will be administered at a dose of 6 mg/kilogram intravenously as a 2-hour infusion, starting Day 1 of Cycle 1 to continue every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year. All participants will receive prednisone 5 mg twice daily starting with the first administration of Mitoxantrone. The duration of treatment will be a maximum of 12 months for cumulative dose. Radiologic assessments will be performed on Week 12 after the first study agent dosing, then every 9 weeks until the end of treatment and then once every 3 months until documented disease progression. Tumor (a mass in a specific area) response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. There will be short-term follow-up visits (conducted monthly for 2 months), followed by long-term follow-up visits (conducted once every 3 months). Participants' safety will also be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitoxantrone+Prednisone+Siltuximab (CNTO 328) (Part 1) | Experimental | In Part 1, mitoxantrone 12 milligram per square meter (mg/m^2) will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kilogram (mg/kg) intravenously as a 2 hour-infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
|
| Mitoxantrone+Prednisone+Siltuximab (Part 2) | Experimental | In Part 2, mitoxantrone 12 mg/m^2 will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
|
| Mitoxantrone+Prednisone (Part 2) | Active Comparator | In Part 2, mitoxantrone 12 mg/m^2 will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoxantrone | Drug | Mitoxantrone 12 mg/m^2 intravenously as a 30 minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Baseline up to 12 weeks after last dose administration |
| Part 2: Progression Free Survival (PFS) | The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first. | Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Deterioration (TtCD) | The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwalk | Connecticut | United States | ||||
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Siltuximab | Drug | Siltuximab 6 mg/kg intravenously as a 2 hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year |
|
|
| Prednisone | Drug | Prednisone 5 mg orally twice daily |
|
| Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years |
| Number of Participants With Palliative Response | Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later. | Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months up to 2 years |
| Number of Participants With Prostate Specific Antigen (PSA) Response | The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response. | Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years |
| Overall Survival (OS) | The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date. | Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years |
| Port Saint Lucie |
| Florida |
| United States |
| Atlanta | Georgia | United States |
| Shreveport | Louisiana | United States |
| Baltimore | Maryland | United States |
| St Louis | Missouri | United States |
| New York | New York | United States |
| Philadelphia | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| North Charleston | South Carolina | United States |
| Milwaukee | Wisconsin | United States |
| Innsbruck | Austria |
| Sankt Veit an der Glan | Austria |
| Vienna | Austria |
| Wels | Austria |
| Aalst | Belgium |
| Antwerp | Belgium |
| Brasschaat | Belgium |
| Brussels | Belgium |
| Roeselare | Belgium |
| Sint-Niklaas | Belgium |
| Wilrijk | Belgium |
| Caen | France |
| Le Mans | France |
| Lyon | France |
| Villejuif | France |
| Berlin | Germany |
| Cologne | Germany |
| Kassel | Germany |
| Barcelona | Spain |
| Madrid | Spain |
| Málaga | Spain |
| London | United Kingdom |
| Sutton | United Kingdom |
| FG001 | Part 2: Mitoxantrone + Prednisone | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
| FG002 | Part 2: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 2 |
|
|
Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone. |
| BG001 | Part 2: Mitoxantrone + Prednisone | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
| BG002 | Part 2: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
| BG003 | 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 | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | Safety population in Part 1 included all participants who received at least one dose of study drug. | Posted | Number | participants | Baseline up to 12 weeks after last dose administration |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 2: Progression Free Survival (PFS) | The PFS is the time from the date of randomization until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first. | Intent-to-treat (ITT) population in Part 2 included all randomized participants. | Posted | Median | 95% Confidence Interval | days | Randomization, Week 12, then every 9 weeks until 1 month after last dose administration, then every 3 months until disease progression or death, up to 2 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Clinical Deterioration (TtCD) | The TtCD is defined as the time from the start of treatment (for participants in Part 1) or randomization (for participants in Part 2) until the first documented clinical deterioration (consists of pain requiring palliative (intended to relieve pain) intervention (a treatment given during the course of a research study), or death due to any cause, whichever occurs earlier. | Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. | Posted | Median | 95% Confidence Interval | days | Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until clinical deterioration or death, up to 2 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Palliative Response | Palliative response was defined as a 2-point or greater reduction from baseline pain, without a categorical increase in prescribed disease-related analgesic (drug used to control pain) use or at least a categorical decrease in disease-related analgesic use without a concomitant (given at the same time) increase in pain. Each component required confirmation at least 3 weeks later. | Data for this outcome measure was not analyzed because minimal efficacy analysis (primary and key secondary endpoints) was done due to early termination of study. | Posted | Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months up to 2 years |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Prostate Specific Antigen (PSA) Response | The PSA response is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value at least 3 weeks after initial documentation of PSA response. | Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Start of treatment (Part 1)/Randomization (Part 2), Week 1 of each cycle up to 1 month after last dose administration, and thereafter every 3 months until disease progression, up to 2 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The OS is defined as the time from the date of start of treatment (for participants in Part 1) or randomization (for participants in Part 2) to death due to any cause. For participants who were alive at the time of analysis, OS was censored at the last contact date. | Analysis population included all participants who received at least one dose of study drug in Part 1 and all randomized participants in Part 2. | Posted | Median | 95% Confidence Interval | days | Start of treatment (Part 1)/Randomization (Part 2) until death, up to 2 years |
|
Baseline up to 12 weeks after last dose administration
Safety population in Part 1 and 2 included all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone. | 5 | 9 | 9 | 9 | ||
| EG001 | Part 2: Mitoxantrone + Prednisone | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. | 18 | 47 | 42 | 47 | ||
| EG002 | Part 2: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. | 18 | 46 | 46 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Catheter Site Haemorrhage | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fibrinolysis | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fibrinolysis Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| International Normalised Ratio Decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Failure to Thrive | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Prostate Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Facial Palsy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Ureteric Obstruction | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pleural Haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Venous Thrombosis | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Gingival Pain | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Temperature Intolerance | General disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Low Density Lipoprotein Increased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Enzyme Abnormality | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Vitamin B12 Deficiency | Metabolism and nutrition disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cerebral Ischaemia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Peripheral Motor Neuropathy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Urinary Bladder Haemorrhage | Renal and urinary disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Postnasal Drip | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 11.0 | Non-systematic Assessment |
|
Results of few secondary endpoints were not reported as the study was terminated early due to the premature suspension and subsequent halting of study enrollment.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Janssen Research & Development | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008942 | Mitoxantrone |
| C504234 | siltuximab |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Lack of Efficacy |
|
| Randomized but not treated |
|
| Other |
|
| Male |
|
| BELGIUM |
|
| FRANCE |
|
| GERMANY |
|
| SPAIN |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
|
|
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
| OG002 | Part 2: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
|
|
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
| OG002 | Part 2: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
|
Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
| OG002 | Part 2: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
|
|
| OG002 | Part 2: Mitoxantrone + Prednisone + Siltuximab | Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. |
|
|