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| ID | Type | Description | Link |
|---|---|---|---|
| CP18-0601 | Other Identifier | ImClone Systems | |
| I4T-IE-JVBS | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC).
Prostate cancer is the most frequently diagnosed cancer in men and the second leading cause of cancer-related death in men in the United States. Chemotherapy, either as a single agent or in combination, may lead to clinical response, pain control, and/or improved quality of life. Docetaxel is now the first-line standard therapy for AIPC. Mitoxantrone was approved in 1996 for use in combination with corticosteroids as initial chemotherapy for pain related to advanced Hormone Refractory Prostate Cancer (HRPC). Hormonal manipulations and docetaxel-based chemotherapy are often effective in metastatic prostate cancer; however, disease becomes refractory to these interventions in the majority of men. Although mitoxantrone continues to be a significant agent in the treatment of HRPC, there exists a need for more efficacious therapy in docetaxel-refractory- AIPC. Because of the potential contribution of Insulin Like Growth Factor Receptor (IGF-IR) and VEGFR-2 mediated pathways in prostate cancer pathogenesis, it is hypothesized that each of these biological agents in combination with mitoxantrone and prednisone will result in clinically meaningful activity in AIPC. Therefore, ImClone plans to conduct a randomized Phase 2 trial to assess the safety and efficacy of IMC-A12 or IMC-1121B (ramucirumab) in combination with mitoxantrone and prednisone in participants with AIPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-1121B (ramucirumab) + Mitoxantrone + Prednisone | Experimental |
| |
| IMC-A12 + Mitoxantrone + Prednisone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-A12 | Biological | IMC-A12 is to be administered as an I.V. infusion, 6 mg/kg over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. IMC-A12 treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Progression-free Survival (cPFS) | Defined as the median time from randomization to the earliest of:
Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy. | Randomization to composite progressive disease, up to 23.4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summary Listing of Participants Reporting Treatment-Emergent Adverse Events | Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. |
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Inclusion Criteria:
The participant has histologically-confirmed adenocarcinoma of the prostate
The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
The participant must have evidence of progressive disease defined as at least one of the following;
The participant has a PSA ≥ 2 ng/mL
The participant has prior surgical or medical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2
The participant has adequate hematologic function (absolute neutrophil count [ANC]≥1500/uL, hemoglobin ≥9 g/dL, and platelets ≥100,000/uL)
The participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal (ULN), Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present)
The participant has adequate renal function (creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 40 mL/min)
The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
The participant has adequate coagulation function (an international normalized ratio [INR] ≤ 1.5 and a Partial Thromboplastin Time [PTT] ≤ 5 seconds above the 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 has a fasting serum glucose level of < 160 mg/dL, or below the ULN
Exclusion Criteria:
The participant has received more than one prior cytotoxic chemotherapy regimen for metastatic disease. (Participants who have had a treatment break followed by a second docetaxel-based regimen with subsequent disease progression are eligible.)
The participant has received prior therapy with mitoxantrone for advanced prostate cancer (prior adjuvant therapy with mitoxantrone is permitted)
The participant has a history of symptomatic congestive heart failure or has a pre-study echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) that is ≥ 10% below the LLN
The participant has received radiotherapy ≤ 21 days prior to first dose of IMC-A12 or Ramucirumab
The participant is receiving corticosteroids (dexamethasone, prednisone, or others) at a dose > 5 mg prednisone orally (PO) two times per day (BID) or equivalent. Participants receiving corticosteroids at higher doses may be eligible if their corticosteroid therapy is tapered to study levels (prednisone 5 mg PO BID) prior to first dose of study medication, without concomitant clinical deterioration
The participant has known or suspected brain or leptomeningeal metastases
The participant has uncontrolled or poorly controlled hypertension
The participant has poorly controlled diabetes mellitus. Inclusion Criteria:
The participant has histologically-confirmed adenocarcinoma of the prostate
The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
The participant must have evidence of progressive disease defined as at least one of the following;
The participant has a PSA ≥ 2 ng/mL
The participant has prior surgical or medical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2
The participant has adequate hematologic function (absolute neutrophil count [ANC]≥1500/uL, hemoglobin ≥9 g/dL, and platelets ≥100,000/uL)
The participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase [AST] and alanine transaminase [ALT]≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present)
The participant has adequate renal function (creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 40 mL/min)
The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
The participant has adequate coagulation function (an international normalized ratio [INR] ≤ 1.5 and a partial thromboplastin time [PTT] ≤ 5 seconds above the 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 has a fasting serum glucose level of < 160 mg/dL, or below the ULN
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 | La Jolla | California | 92093 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26082390 | Derived | Hussain M, Rathkopf D, Liu G, Armstrong A, Kelly WK, Ferrari A, Hainsworth J, Joshi A, Hozak RR, Yang L, Schwartz JD, Higano CS. A randomised non-comparative phase II trial of cixutumumab (IMC-A12) or ramucirumab (IMC-1121B) plus mitoxantrone and prednisone in men with metastatic docetaxel-pretreated castration-resistant prostate cancer. Eur J Cancer. 2015 Sep;51(13):1714-24. doi: 10.1016/j.ejca.2015.05.019. Epub 2015 Jun 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMC-A12 + Mitoxantrone + Prednisone | IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Mitoxantrone | Drug | Mitoxantrone is to be administered as an I.V. infusion, at 12 milligrams/square meter (mg/m^2) over 5-15 minutes on Day 1 during a 3-week (21-day) cycle. Mitoxantrone treatment is to be continued for a maximum of 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m^2) or until there is evidence of disease progression, death, or intolerable toxicity. |
|
| Prednisone | Drug | Prednisone (5 mg) is to be self-administered PO BID, each day of the 21-day cycle. |
|
| IMC-1121B (ramucirumab) | Biological | IMC-1121B (ramucirumab) is to be administered as an intravenous (IV) infusion, 6 milligrams/kilogram (mg/kg) over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. Ramucirumab treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met. |
|
|
| Randomization to 36.3 months |
| Time to Radiographic Evidence of Disease Progression | Time between date of randomization and earliest date of radiographic progression defined as either:
Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy. | Randomization to date of radiographic progression, up to 36.3 months |
| Prostate Specific Antigen (PSA) Response Rate | PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline. | Baseline up to data cut-off date (up to 36.3 months) |
| Composite Progression-free Survival (cPFS) at 6-months | Data presented are the percentage of participants without disease progression at 6 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy. | 6 months |
| Composite Progression-free Survival (cPFS) at 9-months | Data presented are the percentage of participants without disease progression at 9 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy. | 9 months |
| Composite Progression-free Survival (cPFS) at 12-months | Data presented are the percentage of participants without disease progression at 12 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy. | 12 months |
| Overall Survival (OS) | Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive. | First dose to death due to any cause up to 36.3 months |
| Objective Response Rate (ORR) | Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100. | Baseline to date of progressive disease or death up to 36.3 months |
| Maximum Concentration (Cmax) at Study Day 1 | Maximum Concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Day 1 |
| Maximum Concentration (Cmax) at Study Day 15 | Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Day 15 |
| Maximum Concentration (Cmax) at Study Day 16 | Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Day 16 |
| Maximum Concentration (Cmax) at Study Day 30 | Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Day 30 |
| Minimum Concentration (Cmin) at Study Day 1 | Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Day 1 |
| Minimum Concentration (Cmin) at Study Day 15 | Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Day 15 |
| Minimum Concentration (Cmin) at Study Day 16 | Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Day 16 |
| Minimum Concentration (Cmin) at Study Day 30 | Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Day 30 |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| ImClone Investigational Site | Boca Raton | Florida | 33486 | United States |
| ImClone Investigational Site | Port Saint Lucie | Florida | 34952 | United States |
| ImClone Investigational Site | Atlanta | Georgia | 30318 | United States |
| ImClone Investigational Site | Chicago | Illinois | 60611 | United States |
| ImClone Investigational Site | Chlcago | Illinois | 60637 | United States |
| ImClone Investigational Site | Evanston | Illinois | 60201 | United States |
| ImClone Investigational Site | Maryville | Illinois | 62062 | United States |
| ImClone Investigational Site | Cedar Rapids | Iowa | 52402 | United States |
| ImClone Investigational Site | Metairie | Louisiana | 70006 | United States |
| ImClone Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| ImClone Investigational Site | Rochester | Minnesota | 55905 | United States |
| ImClone Investigational Site | St Louis | Missouri | 63110 | United States |
| ImClone Investigational Site | Billings | Montana | 59101 | United States |
| ImClone Investigational Site | Roseland | New Jersey | 07068 | United States |
| ImClone Investigational Site | Buffalo | New York | 14263 | United States |
| ImClone Investigational Site | East Setauket | New York | 11733 | United States |
| ImClone Investigational Site | New York | New York | 10016 | United States |
| ImClone Investigational Site | New York | New York | 10019 | United States |
| ImClone Investigational Site | New York | New York | 10021 | United States |
| ImClone Investigational Site | New York | New York | 10032 | United States |
| ImClone Investigational Site | Durham | North Carolina | 27710 | United States |
| ImClone Investigational Site | Cleveland | Ohio | 44195 | United States |
| ImClone Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| ImClone Investigational Site | Pittsburgh | Pennsylvania | 15232 | United States |
| ImClone Investigational Site | Greenville | South Carolina | 29605 | United States |
| ImClone Investigational Site | Knoxville | Tennessee | 37920 | United States |
| ImClone Investigational Site | Nashville | Tennessee | 37203 | United States |
| ImClone Investigational Site | Abilene | Texas | 79606 | United States |
| ImClone Investigational Site | Dallas | Texas | 75246 | United States |
| ImClone Investigational Site | Houston | Texas | 77030-4009 | United States |
| ImClone Investigational Site | Houston | Texas | 77030 | United States |
| ImClone Investigational Site | Seattle | Washington | 98104 | United States |
| ImClone Investigational Site | Seattle | Washington | 98109 | United States |
| ImClone Investigational Site | Madison | Wisconsin | 53792 | United States |
| FG001 |
| IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone |
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle. |
| Received Any Quantity of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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Modified intent to treat population (mITT): All participants who received any quantity of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | IMC-A12 + Mitoxantrone + Prednisone | IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle. |
| BG001 | IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Progression-free Survival (cPFS) | Defined as the median time from randomization to the earliest of:
Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. 11 participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. 15 participants were censored in the IMC-1121B (ramucirumab) + Mitoxantrone + Prednisone arm. | Median | 95% Confidence Interval | months | Randomization to composite progressive disease, up to 23.4 months |
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| Secondary | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events | Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. | Number | participants | Randomization to 36.3 months |
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| Secondary | Time to Radiographic Evidence of Disease Progression | Time between date of randomization and earliest date of radiographic progression defined as either:
Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. 34 participants were censored in IMC-A12 arm and 34 participants were censored in IMC-1121B (ramucirumab) arm. | Median | 95% Confidence Interval | months | Randomization to date of radiographic progression, up to 36.3 months |
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| Secondary | Prostate Specific Antigen (PSA) Response Rate | PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline. | Participants who received any quantity of study drug, had baseline PSA value >= 2 ng/ml and at least one non-missing post-baseline PSA. | Number | 95% Confidence Interval | percentage of participants | Baseline up to data cut-off date (up to 36.3 months) |
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| Secondary | Composite Progression-free Survival (cPFS) at 6-months | Data presented are the percentage of participants without disease progression at 6 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Composite Progression-free Survival (cPFS) at 9-months | Data presented are the percentage of participants without disease progression at 9 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. | Number | 95% Confidence Interval | percentage of participants | 9 months |
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| Secondary | Composite Progression-free Survival (cPFS) at 12-months | Data presented are the percentage of participants without disease progression at 12 months. Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. | Number | 95% Confidence Interval | percentage of participants | 12 months |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive. | Modified intent to treat population (mITT): All participants who received any quantity of study drug. Nine participants were censored in the IMC-A12 + Mitoxantrone + Prednisone arm. Twelve participants were censored in the IMC-1121B + Mitoxantrone + Prednisone arm | Median | 95% Confidence Interval | months | First dose to death due to any cause up to 36.3 months |
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| Secondary | Objective Response Rate (ORR) | Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100. | Participants with measurable disease at baseline, who received any quantity of study drug. | Number | 95% Confidence Interval | percentage of participants | Baseline to date of progressive disease or death up to 36.3 months |
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| Secondary | Maximum Concentration (Cmax) at Study Day 1 | Maximum Concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Zero participants were analyzed. | Day 1 |
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| Secondary | Maximum Concentration (Cmax) at Study Day 15 | Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Zero participants were analyzed. | Day 15 |
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| Secondary | Maximum Concentration (Cmax) at Study Day 16 | Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Zero participants were analyzed. | Day 16 |
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| Secondary | Maximum Concentration (Cmax) at Study Day 30 | Maximum concentration (Cmax) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Zero participants were analyzed. | Day 30 |
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| Secondary | Minimum Concentration (Cmin) at Study Day 1 | Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Zero participants were analyzed. | Day 1 |
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| Secondary | Minimum Concentration (Cmin) at Study Day 15 | Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Zero participants were analyzed. | Day 15 |
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| Secondary | Minimum Concentration (Cmin) at Study Day 16 | Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Zero participants were analyzed. | Day 16 |
|
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| Secondary | Minimum Concentration (Cmin) at Study Day 30 | Minimum concentration (Cmin) of Ramucirumab. All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted. | Zero participants were analyzed. | Day 30 |
|
|
Not provided
Not provided
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 | IMC-A12 + Mitoxantrone + Prednisone | IMC-A12 intravenous infusion at 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle. | 40 | 66 | 65 | 66 | ||
| EG001 | IMC-1121B (Ramucirumab) + Mitoxantrone + Prednisone | IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle. | 36 | 66 | 66 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment | Event resulted in one death in IMC-1121B arm |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPERTENSIVE CARDIOMYOPATHY | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SICK SINUS SYNDROME | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| RETINAL TEAR | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| RECTAL PERFORATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Event resulted in one death in IMC-1121B arm |
|
| SEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Event resulted in one death in IMC-A12 arm |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| EXPIRED DRUG ADMINISTERED | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| INCORRECT DOSE ADMINISTERED | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| MEDICATION ERROR | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment | Event resulted in death |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| AUTONOMIC NEUROPATHY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CENTRAL NERVOUS SYSTEM MASS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| INTRAVENTRICULAR HAEMORRHAGE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment | Event resulted in one death in IMC-1121B arm |
|
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VASOGENIC CEREBRAL OEDEMA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HAEMORRHAGE URINARY TRACT | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| URINARY BLADDER HAEMORRHAGE | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| TESTICULAR PAIN | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment | Events resulted in two deaths in IMC-A12 arm |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VENA CAVA THROMBOSIS | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| CHROMATURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| PARANASAL SINUS HYPERSECRETION | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| POSTNASAL DRIP | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA 12.0 | 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 |
| D008942 | Mitoxantrone |
| D011241 | Prednisone |
| D000096662 | Ramucirumab |
| 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black Or African American |
|
| Other |
|
|
|
IMC-1121B (ramucirumab) intravenous infusion, 6 milligrams/kilogram (mg/kg) on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone intravenous infusion at 12 milligrams/square meter (mg/m^2) on Day 1 of each 21-day cycle. Prednisone at 5 milligrams (mg) is to be self-administered orally, each day of the 21-day cycle. |
|
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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