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| ID | Type | Description | Link |
|---|---|---|---|
| I5B-IE-JGDD | Other Identifier | Eli Lilly and Company | |
| CP15-0805 | Other Identifier | ImClone Systems | |
| 2009-018015-11 | EudraCT Number |
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This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaratumab + Mitoxantrone | Experimental | 1 cycle = 3 weeks (21 days) |
|
| Mitoxantrone: Optional Olaratumab Monotherapy | Active Comparator | 1 cycle = 3 weeks (21 days) Participants who experience progressive disease (PD) have the option to receive olaratumab monotherapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaratumab | Biological | 15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment. | Randomization to Measured PD or Death Due to Any Cause Up to 23 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. If the participants were alive at the end of the follow-up period or were lost to follow-up, OS time was censored on the last date the participant was known to be alive. | Randomization to Death Due to Any Cause Up to 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died During Study | From Start of Treatment through Study Completion up to 36 Months |
Inclusion Criteria:
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 | Charleroi | 6000 | Belgium | |||
| ImClone Investigational Site |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
A participant was considered to have completed the study if he or she experienced progressive disease (PD) or had died.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olaratumab (IMC-3G3) + Mitoxantrone | 15 milligrams per kilogram (mg/kg) olaratumab was administered intravenously (IV) on Days 1 and 8 of each 21-day cycle, followed by 12 milligrams per square meter (mg/m²) mitoxantrone IV on Day 1 of each 21-day cycle with 5 milligrams (mg) prednisone orally (PO) twice daily (BID) on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization Treatment |
|
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| Mitoxantrone | Drug | Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1 Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²) |
|
| Prednisone | Drug | 5 mg orally (PO) twice daily (BID) on each day |
|
| Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Best response is categorized using the RECIST v1.1 guidelines. CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is a ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the pretreatment sum diameter. Percentage of participants = (number of participants who had CR or PR) / (number of participants treated) * 100. | Randomization to Objective PD or Death Up to 23 Months |
| Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time | Decrease in PSA ≥50% from pretreatment required confirmation no less than 3 weeks after the initial suggestion of response and occurring prior to documentation of PD. Percentage of participants = (number of participants who had ≥50% decrease in PSA at any time) / (number of participants treated) * 100. | Pretreatment to PD Up to 23 Months |
| Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12 | Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) * 100. | Pretreatment through Week 12 |
| Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | Data presented are the number of participants who experienced serious adverse events (SAEs) and other nonserious adverse events (AEs). For participants in mitoxantrone group who had PD and chose optional IMC-3G3 follow-on treatment, the baseline was defined as the last assessment prior to the start of the olaratumab treatment. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section. | From Start of Treatment Through Study Completion Up to 36 months |
| PFS Based on Baseline Circulating Tumor Cells (CTC) Counts | High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL) and low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. | Randomization to Measured PD or Death Due to Any Cause Up to 23 Months |
| OS Based on Baseline CTC Counts | HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL and LE of CTC was defined as having CTC counts <5 cells/7.5 mL. OS was defined as the time from the date of randomization to the date of death from any cause. | Randomization to Death Due to Any Cause Up to 36 Months |
| Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC) | PDGFRα protein expression (pretreatment) by IHC was assessed in tumor cells, and was provided as a dichotomous variable with "positive" and "negative" expression. "Positive" corresponds to weak intensity membranous staining comprising greater than 30% of the tumor and/or moderate to strong intensity membranous staining comprising greater than 5% of the tumor. "Negative" corresponds to staining that does not meet these requirements. | Baseline |
| Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity) | Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. | From Start of Treatment up to 9 Months |
| Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3 | Day 1 of Cycles 1, 2 and 3, and Day 8 of Cycles 1 and 3 (21-day cycle) |
| Edegem |
| 2650 |
| Belgium |
| ImClone Investigational Site | Liège | 4000 | Belgium |
| ImClone Investigational Site | Olomouc | 77520 | Czechia |
| ImClone Investigational Site | Prague | 12808 | Czechia |
| ImClone Investigational Site | Prague | 15006 | Czechia |
| ImClone Investigational Site | Aachen | 57074 | Germany |
| ImClone Investigational Site | Augsburg | 86150 | Germany |
| ImClone Investigational Site | Bonn | 53177 | Germany |
| ImClone Investigational Site | Dresden | 01307 | Germany |
| ImClone Investigational Site | Essen | 45122 | Germany |
| ImClone Investigational Site | Frankfurt | 60590 | Germany |
| ImClone Investigational Site | Freiburg im Breisgau | 79106 | Germany |
| ImClone Investigational Site | Mainz | 55131 | Germany |
| ImClone Investigational Site | Mannheim | 68167 | Germany |
| ImClone Investigational Site | Münster | 48149 | Germany |
| ImClone Investigational Site | Rostock | 18055 | Germany |
| ImClone Investigational Site | Budapest | 1106 | Hungary |
| ImClone Investigational Site | Debrecen | 4032 | Hungary |
| ImClone Investigational Site | Kecskemét | 6000 | Hungary |
| ImClone Investigational Site | Miskolc | 3526 | Hungary |
| ImClone Investigational Site | Nyíregyháza | 4400 | Hungary |
| ImClone Investigational Site | Pécs | 7624 | Hungary |
| ImClone Investigational Site | Szeged | 6725 | Hungary |
| ImClone Investigational Site | Meldola | 47014 | Italy |
| ImClone Investigational Site | Milan | 20123 | Italy |
| ImClone Investigational Site | Roma | 161 | Italy |
| ImClone Investigational Site | Rozzano | 20089 | Italy |
| ImClone Investigational Site | Trento | 38100 | Italy |
| ImClone Investigational Site | Krakow | 31-115 | Poland |
| ImClone Investigational Site | Lublin | 20-090 | Poland |
| ImClone Investigational Site | Poznan | 61-485 | Poland |
| ImClone Investigational Site | Warsaw | 02-781 | Poland |
| ImClone Investigational Site | Barcelona | 8003 | Spain |
| ImClone Investigational Site | Barcelona | 8036 | Spain |
| ImClone Investigational Site | Madrid | 28041 | Spain |
| ImClone Investigational Site | Palma de Mallorca | 7014 | Spain |
| ImClone Investigational Site | Pamplona - Navarra | 31008 | Spain |
| ImClone Investigational Site | Sabadell - Barcelona | 8208 | Spain |
| ImClone Investigational Site | Valencia | 46014 | Spain |
| FG001 | Mitoxantrone: Optional Olaratumab Monotherapy | 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met. |
| Received ≥1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Optional Olaratumab Monotherapy |
|
|
All randomized participants who received ≥1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Olaratumab + Mitoxantrone | 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met. |
| BG001 | Mitoxantrone: Optional Olaratumab Monotherapy | 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | PFS is measured from randomization to the earliest date of the following events: PD according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1, is a ≥20% increase in the sum of diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 millimeter (mm), the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. For participants who had no documented PD or death or had started new anti-cancer therapy or were lost to follow-up, PFS was censored at their last tumor assessment. | All randomized participants who received ≥1 dose of study drug. The number of participants censored was 10 for olaratumab + mitoxantrone group and 5 for mitoxantrone group. | Posted | Median | 95% Confidence Interval | months | Randomization to Measured PD or Death Due to Any Cause Up to 23 Months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. If the participants were alive at the end of the follow-up period or were lost to follow-up, OS time was censored on the last date the participant was known to be alive. | All randomized participants who received ≥1 dose of study drug. The number of participants censored was 12 for olaratumab + mitoxantrone group and 13 for mitoxantrone group. | Posted | Median | 95% Confidence Interval | months | Randomization to Death Due to Any Cause Up to 36 Months |
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| Secondary | Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Best response is categorized using the RECIST v1.1 guidelines. CR is the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is a ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the pretreatment sum diameter. Percentage of participants = (number of participants who had CR or PR) / (number of participants treated) * 100. | All randomized participants who received at least ≥1 dose of study drug and had measurable disease. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Objective PD or Death Up to 23 Months |
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| Secondary | Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time | Decrease in PSA ≥50% from pretreatment required confirmation no less than 3 weeks after the initial suggestion of response and occurring prior to documentation of PD. Percentage of participants = (number of participants who had ≥50% decrease in PSA at any time) / (number of participants treated) * 100. | All randomized participants who received ≥1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Pretreatment to PD Up to 23 Months |
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| Secondary | Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12 | Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) * 100. | All randomized participants who received ≥1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Pretreatment through Week 12 |
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| Secondary | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | Data presented are the number of participants who experienced serious adverse events (SAEs) and other nonserious adverse events (AEs). For participants in mitoxantrone group who had PD and chose optional IMC-3G3 follow-on treatment, the baseline was defined as the last assessment prior to the start of the olaratumab treatment. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From Start of Treatment Through Study Completion Up to 36 months |
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| Secondary | PFS Based on Baseline Circulating Tumor Cells (CTC) Counts | High expression (HE) of CTC was defined as having CTC counts ≥5 cells/7.5 milliliter (mL) and low expression (LE) of CTC was defined as having CTC counts <5 cells/7.5 mL. PFS is measured from randomization to the earliest date of the following events: PD according to RECIST criteria v. 1.1, is a ≥20% increase in the sum diameter of the target lesions taking as reference the smallest sum on study and an absolute increase in the sum diameter of ≥5 mm, the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions, unequivocal evidence of progression by bone scan, clinical progression or death from any cause. | All randomized participants who had evaluable data for CTC counts at baseline. The CTC counts assessment across both arms, high and low expression, was pre-specified in the statistical analysis plan. | Posted | Median | 95% Confidence Interval | months | Randomization to Measured PD or Death Due to Any Cause Up to 23 Months |
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| Secondary | OS Based on Baseline CTC Counts | HE of CTC was defined as having CTC counts ≥5 cells/7.5 mL and LE of CTC was defined as having CTC counts <5 cells/7.5 mL. OS was defined as the time from the date of randomization to the date of death from any cause. | All randomized participants who had evaluable data for CTC counts at baseline. The CTC counts assessment across both arms, high and low expression, was pre-specified in the statistical analysis plan. | Posted | Median | 95% Confidence Interval | months | Randomization to Death Due to Any Cause Up to 36 Months |
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| Secondary | Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC) | PDGFRα protein expression (pretreatment) by IHC was assessed in tumor cells, and was provided as a dichotomous variable with "positive" and "negative" expression. "Positive" corresponds to weak intensity membranous staining comprising greater than 30% of the tumor and/or moderate to strong intensity membranous staining comprising greater than 5% of the tumor. "Negative" corresponds to staining that does not meet these requirements. | All randomized participants who received at least 1 dose of study drug and provided tissue specimens from the initial diagnosis for PDGFRα protein expression analysis. | Posted | Number | participants | Baseline |
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| Other Pre-specified | Number of Participants Who Died During Study | All randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From Start of Treatment through Study Completion up to 36 Months |
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| Secondary | Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity) | Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. | All randomized participants who received ≥1 dose of study drug and had evaluable baseline and evaluable post-baseline antibody data. The participants analyzed under Mitoxantrone are those in control arm receiving subsequent optional olaratumab monotherapy. | Posted | Number | percent of participants | From Start of Treatment up to 9 Months |
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| Secondary | Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3 | Zero participants were analyzed. An insufficient amount of samples were collected to obtain this measure. | Posted | Day 1 of Cycles 1, 2 and 3, and Day 8 of Cycles 1 and 3 (21-day cycle) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olaratumab + Mitoxantrone | 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). After 12 cycles, participants continued to receive 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day until withdrawal criteria were met. | 26 | 62 | 52 | 62 | ||
| EG001 | Mitoxantrone | 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). | 21 | 59 | 51 | 59 | ||
| EG002 | Mitoxantrone: Optional Olaratumab Monotherapy | 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). Participants who experienced PD had the option to receive olaratumab monotherapy treatment.15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met. | 6 | 19 | 15 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anaemia of malignant disease | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Gastroenteritis escherichia coli | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Incorrect dose administered | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypovitaminosis | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vitamin b12 deficiency | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
Efficacy analysis for the follow-on treatment is exploratory, therefore, efficacy analysis for follow-on treatment are not included in this clinical trial results.
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 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. 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 |
|---|---|
| C000589393 | olaratumab |
| D008942 | Mitoxantrone |
| 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
| Withdrawal by Subject |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Spain |
|
| Poland |
|
| Belgium |
|
| Germany |
|
| Italy |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| OG002 | Mitoxantrone: Optional Olaratumab Monotherapy | 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). Participants who experienced PD had the option to receive olaratumab monotherapy treatment. 15 mg/kg olaratumab was administered IV on Days 1 and 8 of each 21-day cycle with 5 mg prednisone PO BID on each day. Participants received treatment until withdrawal criteria were met. |
|
|
12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day.
Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²).
| OG002 | Olaratumab + Mitoxantrone (LE) | Participants with CTC counts <5 cells/7.5 mL at baseline received 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). |
| OG003 | Mitoxantrone (LE) | 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). |
|
|
Participants with CTC counts <5 cells/7.5 mL at baseline received 15 mg/kg olaratumab IV on Days 1 and 8 of each 21-day cycle, followed by 12 mg/m² mitoxantrone IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone was restricted to ≤144 mg/m²). |
| OG003 | Mitoxantrone (LE) | 12 mg/m² mitoxantrone was administered IV on Day 1 of each 21-day cycle with 5 mg prednisone PO BID on each day. Mitoxantrone was administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²). |
|
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