Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
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.
Interventions
BIOLOGICALOlaratumab
15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8
DRUGMitoxantrone
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)
DRUGPrednisone
5 mg orally (PO) twice daily (BID) on each day
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically-confirmed adenocarcinoma of the prostate * radiographic evidence of metastatic prostate cancer (Stage M1 or D2) * has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of \<50 nanograms per milliliter (ng/mL) * has had disease progression or intolerance on docetaxel-based therapy * prostate-specific antigen (PSA) ≥10 ng/mL * all clinically significant toxic effects of prior surgery, radiotherapy, chemotherapy or hormonal therapy have resolved to ≤Grade 1, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.02 * participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * adequate hematologic function * adequate hepatic function * adequate renal function * urinary protein is ≤1 on dipstick or routine analysis * life expectancy of more than 3 months * fertile man with partners that are women of childbearing potential must use an adequate method of contraception during the study * signed Informed Consent Document
Exclusion criteria
* concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms * The participant has received more than 1 prior cytotoxic chemotherapy regimen for metastatic disease * prior therapy with mitoxantrone for advanced prostate cancer * The participant has a history of symptomatic congestive heart failure or has a pre study echocardiogram or multigated acquisition scan with left ventricular ejection fraction that is ≥10% below the lower limit of normal institutional range * history of prior treatment with other agents that directly inhibit platelet-derived growth factor (PDGF) or platelet-derived growth factor receptors (PDGFR) * known allergy to any of the treatment components: olaratumab, mitoxantrone, and/or prednisone * radiotherapy within 21 days prior to first dose of olaratumab * any investigational therapy within 30 days of randomization * is receiving corticosteroids at a dose \>5 mg prednisone PO BID or equivalent * received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain * has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders * known or suspected brain or leptomeningeal metastases * known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Randomization to Measured PD or Death Due to Any Cause Up to 23 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Randomization to Death Due to Any Cause Up to 36 Months | 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. |
| Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Randomization to Objective PD or Death Up to 23 Months | 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. |
| Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time | Pretreatment to PD Up to 23 Months | 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. |
| Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12 | Pretreatment through Week 12 | Percentage of participants = (number of participants who had ≥30% decrease in PSA at Week 12) / (number of participants treated) \* 100. |
| Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | From Start of Treatment Through Study Completion Up to 36 months | 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. |
| PFS Based on Baseline Circulating Tumor Cells (CTC) Counts | Randomization to Measured PD or Death Due to Any Cause Up to 23 Months | 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. |
| OS Based on Baseline CTC Counts | Randomization to Death Due to Any Cause Up to 36 Months | 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. |
| Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC) | Baseline | 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. |
| Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity) | From Start of Treatment up to 9 Months | 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. |
| 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) | — |
Other
| Measure | Time frame |
|---|---|
| Number of Participants Who Died During Study | From Start of Treatment through Study Completion up to 36 Months |
Countries
Belgium, Czechia, Germany, Hungary, Italy, Poland, Spain
Participant flow
Pre-assignment details
A participant was considered to have completed the study if he or she experienced progressive disease (PD) or had died.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 62 |
| 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. | 59 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Optional Olaratumab Monotherapy | Olaratumab Intolerance | 0 | 1 |
| Optional Olaratumab Monotherapy | Physician Decision | 0 | 1 |
| Optional Olaratumab Monotherapy | Withdrawal by Subject | 0 | 1 |
| Randomization Treatment | Adverse Event | 4 | 2 |
| Randomization Treatment | Entry criteria not met | 0 | 1 |
| Randomization Treatment | Lost to Follow-up | 1 | 0 |
| Randomization Treatment | Moved and Followed for Survival | 0 | 1 |
| Randomization Treatment | Physician Decision | 3 | 2 |
| Randomization Treatment | Sponsor Decision | 0 | 1 |
| Randomization Treatment | Withdrawal by Subject | 6 | 5 |
| Randomization Treatment | Worsening of General condition | 0 | 1 |
Baseline characteristics
| Characteristic | Olaratumab + Mitoxantrone | Total | Mitoxantrone: Optional Olaratumab Monotherapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 42 Participants | 86 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 35 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 116 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 62 Participants | 120 Participants | 58 Participants |
| Region of Enrollment Belgium | 3 Participants | 5 Participants | 2 Participants |
| Region of Enrollment Czechia | 5 Participants | 7 Participants | 2 Participants |
| Region of Enrollment Germany | 15 Participants | 31 Participants | 16 Participants |
| Region of Enrollment Hungary | 6 Participants | 16 Participants | 10 Participants |
| Region of Enrollment Italy | 5 Participants | 16 Participants | 11 Participants |
| Region of Enrollment Poland | 11 Participants | 17 Participants | 6 Participants |
| Region of Enrollment Spain | 17 Participants | 29 Participants | 12 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 62 Participants | 121 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 52 / 62 | 51 / 59 | 15 / 19 |
| serious Total, serious adverse events | 26 / 62 | 21 / 59 | 6 / 19 |
Outcome results
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.
Time frame: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Olaratumab + Mitoxantrone | Progression-Free Survival (PFS) | 2.3 months |
| Mitoxantrone | Progression-Free Survival (PFS) | 2.4 months |
p-value: 0.220195% CI: [0.87, 1.9]Log Rank
Secondary
Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3
Time frame: Day 1 of Cycles 1, 2 and 3, and Day 8 of Cycles 1 and 3 (21-day cycle)
Population: Zero participants were analyzed. An insufficient amount of samples were collected to obtain this measure.
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olaratumab + Mitoxantrone | Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC) | 14 participants |
| Mitoxantrone | Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC) | 9 participants |
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.
Time frame: Randomization to Death Due to Any Cause Up to 36 Months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Olaratumab + Mitoxantrone | OS Based on Baseline CTC Counts | 12.85 months |
| Mitoxantrone | OS Based on Baseline CTC Counts | 8.10 months |
| Mitoxantrone: Optional Olaratumab Monotherapy | OS Based on Baseline CTC Counts | 16.49 months |
| Mitoxantrone (LE) | OS Based on Baseline CTC Counts | 23.00 months |
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.
Time frame: Randomization to Death Due to Any Cause Up to 36 Months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Olaratumab + Mitoxantrone | Overall Survival (OS) | 14.2 months |
| Mitoxantrone | Overall Survival (OS) | 12.8 months |
p-value: 0.729195% CI: [0.72, 1.61]Log Rank
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.
Time frame: Randomization to Objective PD or Death Up to 23 Months
Population: All randomized participants who received at least ≥1 dose of study drug and had measurable disease.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olaratumab + Mitoxantrone | Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | 10.0 percentage of participants |
| Mitoxantrone | Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | 3.1 percentage of participants |
p-value: 0.3465Fisher Exact
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.
Time frame: Pretreatment through Week 12
Population: All randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olaratumab + Mitoxantrone | Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12 | 22.6 percentage of participants |
| Mitoxantrone | Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12 | 16.9 percentage of participants |
p-value: 0.4986Fisher Exact
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.
Time frame: Pretreatment to PD Up to 23 Months
Population: All randomized participants who received ≥1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olaratumab + Mitoxantrone | Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time | 22.6 percentage of participants |
| Mitoxantrone | Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time | 18.6 percentage of participants |
p-value: 0.6571Fisher Exact
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.
Time frame: From Start of Treatment up to 9 Months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olaratumab + Mitoxantrone | Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity) | 3.8 percent of participants |
| Mitoxantrone | Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity) | 0 percent of participants |
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.
Time frame: Randomization to Measured PD or Death Due to Any Cause Up to 23 Months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Olaratumab + Mitoxantrone | PFS Based on Baseline Circulating Tumor Cells (CTC) Counts | 2.32 months |
| Mitoxantrone | PFS Based on Baseline Circulating Tumor Cells (CTC) Counts | 2.23 months |
| Mitoxantrone: Optional Olaratumab Monotherapy | PFS Based on Baseline Circulating Tumor Cells (CTC) Counts | 2.38 months |
| Mitoxantrone (LE) | PFS Based on Baseline Circulating Tumor Cells (CTC) Counts | 4.91 months |
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.
Time frame: From Start of Treatment Through Study Completion Up to 36 months
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olaratumab + Mitoxantrone | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | SAEs | 26 participants |
| Olaratumab + Mitoxantrone | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | AEs | 52 participants |
| Mitoxantrone | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | SAEs | 21 participants |
| Mitoxantrone | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | AEs | 51 participants |
| Mitoxantrone: Optional Olaratumab Monotherapy | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | SAEs | 6 participants |
| Mitoxantrone: Optional Olaratumab Monotherapy | Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) | AEs | 15 participants |
Other Pre-specified
Number of Participants Who Died During Study
Time frame: From Start of Treatment through Study Completion up to 36 Months
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olaratumab + Mitoxantrone | Number of Participants Who Died During Study | Due to Other reasons | 3 participants |
| Olaratumab + Mitoxantrone | Number of Participants Who Died During Study | Due to AEs | 4 participants |
| Olaratumab + Mitoxantrone | Number of Participants Who Died During Study | Due to PD | 43 participants |
| Mitoxantrone | Number of Participants Who Died During Study | Due to Other reasons | 2 participants |
| Mitoxantrone | Number of Participants Who Died During Study | Due to PD | 27 participants |
| Mitoxantrone | Number of Participants Who Died During Study | Due to AEs | 3 participants |
| Mitoxantrone: Optional Olaratumab Monotherapy | Number of Participants Who Died During Study | Due to AEs | 1 participants |
| Mitoxantrone: Optional Olaratumab Monotherapy | Number of Participants Who Died During Study | Due to PD | 12 participants |
| Mitoxantrone: Optional Olaratumab Monotherapy | Number of Participants Who Died During Study | Due to Other reasons | 1 participants |