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| ID | Type | Description | Link |
|---|---|---|---|
| CP13-0603 | Other Identifier | ImClone Systems | |
| I5A-IE-JAEJ | Other Identifier | Eli Lilly and Company |
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This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Non-surgically castrated participants must continue the use of luteinizing hormone-releasing hormone (LHRH) agonists during protocol treatment.
Thirty-one chemotherapy-naїve participants with asymptomatic metastatic androgen-independent prostate cancer will be enrolled and treated with intravenous (i.v.) IMC-A12 (Cixutumumab) at 10 milligrams per kilogram (mg/kg) administered over 1 hour every 2 weeks. An additional 10 participants will be enrolled and treated with IMC-A12 at a dose of 20 mg/kg every three weeks. Treatment will continue until evidence of disease progression or intolerable toxicity. Radiographic evaluation of response will be performed every 8 weeks for the participants treated with i.v. IMC-A12 at 20 mg/kg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-A12 | Experimental | Thirty-one participants will receive IMC-A12 at 10 milligrams per kilogram (mg/kg) administered over 1 hour every other week (every 14 days). An additional 10 participants will receive IMC-A12 at a dose of 20 mg/kg every three weeks. Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Radiographic evaluation of response will be performed every 8 weeks for the participants treated with intravenous (i.v.) IMC-A12 at 10 mg/kg and every 9 weeks for the participants treated with i.v. IMC-A12 at 20 mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-A12 (Cixutumumab) | Drug | 10 mg/kg i.v. infusion over 1 hour every 2 weeks or 20 mg/kg i.v. infusion over 1 hour every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab | cTTP was the time from the first day of treatment to the earliest onset of 1 of the following: tumor progression by Response Evaluation Criteria In Solid Tumors [RECIST, version 1.0] criteria: unequivocal evidence of progression by bone scan, new skeletal events, symptomatic progression (for participants without measurable disease), or other clinical events attributable to prostate cancer that in the opinion of the investigator require major interventions. Participants without tumor progression at data cut-off were censored. | From first dose of study drug until progressive disease (Up to 49.2 months) |
| Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks | Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h postdose for Cycle 4; predose and 1 h post dose for Cycles 5 to 9) | |
| Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks | Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h post dose for Cycle 4; predose and 1 h postdose for Cycles 5 to 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) | Clinically significant events were defined as SAEs and other non-serious adverse events AEs. Participants who died due to progressive disease (PD), AEs while on treatment or died during the 30 day post-treatment are included. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. |
Not provided
Inclusion Criteria
The participant is male and at least 18 years of age
The participant has histologically-confirmed adenocarcinoma of the prostate
The participant has radiographic evidence of metastatic prostate cancer (stage M1 [D2])
The participant has prostate cancer unresponsive or refractory to hormone therapy
The participant must have evidence of progressive disease defined as at least one of the following:
The participant has a PSA ≥ 2 nanograms/milliliter (ng/mL)
The participant has not received prior chemotherapy for metastatic prostate cancer
The participant had prior surgical or medical castration with a serum testosterone level of < 50 ng/mL. If the method of castration is LHRH agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
All clinically significant toxic effects (excluding alopecia) of prior surgery, radiotherapy, or hormonal therapy have resolved to grade ≤ 1 based on National Cancer Institute - Common Terminology Criteria for Adverse Events, (NCI-CTCAE)Version 3.0
The participant has not received antiandrogen therapy for at least 6 weeks (4 weeks for flutamide) prior to study entry and is without evidence of an antiandrogen withdrawal response. For participants whose progression is documented solely by PSA increase, the most recent PSA value enabling study entry must be drawn after the required antiandrogen washout period
The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1
The participant has adequate organ function including: absolute neutrophil count ≥ 1500/microliter (μL); platelets ≥ 100,000/μL; hemoglobin ≥ 9.0 grams per deciliter (g/dL); bilirubin ≤ 1.5 times the institutional upper limit of normal (ULN); aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 3 times ULN (< 5x ULN if liver metastases are present); creatinine ≤ 1.5 x ULN (or calculated creatinine clearance > 60 milliliter/minute (mL/min); and urine protein ≤ 1+ (if urine protein is ≥ 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study)
The participant has fasting serum glucose < 120 milligrams per deciliter (mg/dL) or below the ULN
The participant has adequate coagulation function as defined by an international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 ULN (unless on oral anticoagulant therapy). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3)
The participant is asymptomatic from prostate cancer. Participants with minimal, infrequent cancer-related symptoms are eligible. Criteria regarding pain and analgesic use are detailed below
The participant has a life expectancy > 6 months
The participant, if sexually active, agrees to use contraceptives while on study
The participant has provided signed informed consent
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | San Francisco | California | 94115 | United States | ||
| ImClone Investigational Site |
Participants who had results for the primary outcome measures were considered to have completed the study. The primary outcome measure is: Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMC-A12 (Cixutumumab) 10 mg/kg | Cixutumumab was administered at 10 milligrams/kilogram (mg/kg) as intravenous (i.v.) infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity. |
| FG001 | Cixutumumab 20 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From randomization up to 49.2 months (and 30 day follow-up) |
| Time to Radiographically Evident Disease Progression | This is the time between first dose and radiographic progression defined as either: progression of measurable or non measurable lesions using the RECIST v 1.0, evidence of progression by bone scan or new skeletal event including new pathologic bone fracture, new bone lesion requiring radiation or surgery, or spinal cord/nerve root compression. Participants without evidence of disease progression at the date of latest tumor or bone radiograph were censored. | From first dose of study drug until radiographic progression (up to 48.6 months) |
| Number of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate) | Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of longest diameter of target lesions | From Randomization up to progressive disease (49.2 months) |
| Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate | Percentage of participants with a PSA decrease of at least 50% from baseline PSA provided the participant had a PSA value of at least 2 nanograms per milliliter (ng/ml) at baseline. Percentage calculated as: (number of participants with PSA response rate / total number of participants) *100. | From Randomization up to 6.21 months |
| Progression-Free Survival (PFS) Rate at 6 Months | PFS rate was the proportion of participants who had stable disease (SD), PR, or CR and were alive at 6 months after receiving their first dose of study medication. Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in sum of longest diameter of target lesions, and SD was defined as shrinkage or increase in tumor size that did not meet the above criteria. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. Percentage of participants = (Number of participants with PFS at 6 months / total number of participants analyzed) *100. | From randomization up to 48.6 months |
| Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks | Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only) |
| Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks | Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only) |
| Portland |
| Oregon |
| 97239 |
| United States |
| ImClone Investigational Site | Seattle | Washington | 98109 | United States |
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity.
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cixutumumab 10 mg/kg | Cixutumumab was administered at 10 mg/kg as i.v. infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity. |
| BG001 | Cixutumumab 20 mg /kg | Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity. |
| 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 | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Composite Time to Disease Progression (cTTP) for Participants Treated With Cixutumumab | cTTP was the time from the first day of treatment to the earliest onset of 1 of the following: tumor progression by Response Evaluation Criteria In Solid Tumors [RECIST, version 1.0] criteria: unequivocal evidence of progression by bone scan, new skeletal events, symptomatic progression (for participants without measurable disease), or other clinical events attributable to prostate cancer that in the opinion of the investigator require major interventions. Participants without tumor progression at data cut-off were censored. | ITT population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg =7; or Cixutumumab 20 mg/kg = 2. | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until progressive disease (Up to 49.2 months) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks | Zero participants were analyzed as the data were not estimable accurately due to the study sampling schedule. | Posted | Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h postdose for Cycle 4; predose and 1 h post dose for Cycles 5 to 9) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 20 mg/kg Every 3 Weeks | Participants who received study drug and had evaluable pharmacokinetic (PK) samples for Cmax on Cycle 1 and Cycle 5. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/ml) | Up to 42 months (predose, 1, 168, 336 and 504 h postdose for Cycles 1 to 4; additionally 24, 72 or 96 h, 120 and 240 or 246 h post dose for Cycle 4; predose and 1 h postdose for Cycles 5 to 9) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) | Clinically significant events were defined as SAEs and other non-serious adverse events AEs. Participants who died due to progressive disease (PD), AEs while on treatment or died during the 30 day post-treatment are included. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Safety population: All participants who received any dose of Cixutumumab. | Posted | Count of Participants | Participants | No | From randomization up to 49.2 months (and 30 day follow-up) |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Radiographically Evident Disease Progression | This is the time between first dose and radiographic progression defined as either: progression of measurable or non measurable lesions using the RECIST v 1.0, evidence of progression by bone scan or new skeletal event including new pathologic bone fracture, new bone lesion requiring radiation or surgery, or spinal cord/nerve root compression. Participants without evidence of disease progression at the date of latest tumor or bone radiograph were censored. | ITT population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg = 9; Cixutumumab 20 mg/kg = 2. | Posted | Median | 95% Confidence Interval | months | From first dose of study drug until radiographic progression (up to 48.6 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complete Response (CR) or Partial Response (PR) (Tumor Response Rate) | Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in sum of longest diameter of target lesions | Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From Randomization up to progressive disease (49.2 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate | Percentage of participants with a PSA decrease of at least 50% from baseline PSA provided the participant had a PSA value of at least 2 nanograms per milliliter (ng/ml) at baseline. Percentage calculated as: (number of participants with PSA response rate / total number of participants) *100. | Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From Randomization up to 6.21 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Rate at 6 Months | PFS rate was the proportion of participants who had stable disease (SD), PR, or CR and were alive at 6 months after receiving their first dose of study medication. Response was defined using RECIST v1.0 criteria: CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in sum of longest diameter of target lesions, and SD was defined as shrinkage or increase in tumor size that did not meet the above criteria. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. Percentage of participants = (Number of participants with PFS at 6 months / total number of participants analyzed) *100. | Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug. Participants censored: Cixutumumab 10 mg/kg - 7; Cixutumumab 20 mg/kg = 2. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 48.6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks | Zero participants were analyzed as the data were not estimable accurately due to the study sampling schedule. | Posted | Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Maximum Concentration (Cmax) of IMC-A12 Administered at a Dose of 10 mg/kg Every 2 Weeks | Participants who received study drug and had evaluable PK samples for Cmax on Cycle 1 only in 10 mg/kg group. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/ml | Up to 42 months (predose and 1 h postdose for Cycles 1, 5, 9, 13, 17 and 21; additionally immediately following dosing, 168 and 336 h postdose for Cycle 1 only) |
|
|
From Randomization up to 49.2 months (and 30-day follow-up)
Study-specific clinical outcomes due to progressive disease were not considered to be serious adverse events (SAEs) unless it was deemed related to study drug by the investigator.
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 | Cixutumumab 10 mg/kg | Cixutumumab was administered at 10 mg/kg as intravenous (i.v.) infusion over 1 hour every 2 weeks until disease progression or intolerable toxicity. | 6 | 31 | 28 | 31 | ||
| EG001 | Cixutumumab 20 mg/kg | Cixutumumab was administered at 20mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity. | 0 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| TROPONIN I INCREASED | Investigations | MedDRA 8.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| LEUKOENCEPHALOPATHY | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| VERTEBRAL ARTERY OCCLUSION | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | Cardiac disorders | MedDRA 8.0 | Systematic Assessment |
| |
| EAR DISORDER | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 8.0 | Systematic Assessment |
| |
| EYELID OEDEMA | Eye disorders | MedDRA 8.0 | Systematic Assessment |
| |
| VISUAL DISTURBANCE | Eye disorders | MedDRA 8.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| DYSGEUSIA | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 8.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 8.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 8.0 | Systematic Assessment |
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| INFUSION RELATED REACTION | General disorders | MedDRA 8.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 8.0 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA 8.0 | Systematic Assessment |
| |
| NAIL INFECTION | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 8.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 8.0 | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 8.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| SHOULDER PAIN | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| BALANCE DISORDER | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| DYSPHONIA | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| HYPOAESTHESIA | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| INSOMNIA | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA 8.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 8.0 | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
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| PROTEINURIA | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
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| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 8.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | Systematic Assessment |
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| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| ERYTHEMA OF EYELID | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 8.0 | Systematic Assessment |
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| EPISTAXIS | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 8.0 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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 |
|---|---|
| C557414 | cixutumumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Hispanic |
|
|
|
| Participants |
|
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|
|
Cixutumumab was administered at 20 mg/kg as i.v. infusion over 1 hour every 3 weeks until disease progression or intolerable toxicity. |
|
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