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| ID | Type | Description | Link |
|---|---|---|---|
| I5B-MC-JGDR | Other Identifier | Eli Lilly and Company | |
| 2016-004287-19 | EudraCT Number |
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The purpose of this study is to evaluate the safety of ifosfamide when added to the combination regimen of olaratumab and doxorubicin in participants with advanced or metastatic soft tissue sarcoma (STS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaratumab + Doxorubicin + Ifosfamide + Mesna | Experimental | Olaratumab 15 milligrams per kilogram (mg/kg) on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin and ifosfamide was administered. When the safety of the 15-mg/kg dose of olaratumab was established, a 20-mg/kg loading dose cycle of olaratumab on Days 1 and 8 of a 21-day cycle in Cycle 1 only, followed by 15 mg/kg on Days 1 and 8 of subsequent cycles in combination with doxorubicin and ifosfamide plus mesna, was administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaratumab | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs) | A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the NCI-CTCAE Version 4.0:
| Cycle 1 (Up To 24 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | PK: Cmax of olaratumab. | Cycle 1 - Day 1 (predose, end of infusion, 2 hours post olaratumab (olara), 6 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 6 hours post olara, 48 hours post olara, 168 hours post olara) |
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Inclusion Criteria:
Have a histological diagnosis of advanced STS (by local pathology review), for which treatment with doxorubicin, ifosfamide and mesna is deemed appropriate by the investigator.
Have measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Have adequate hematologic, organ and coagulation function within 2 weeks (14 days) prior to enrollment.
Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale.
Have received no prior lines of systemic therapy and are suitable to receive doxorubicin, ifosfamide and mesna. All previous anticancer treatments must have completed ≥3 weeks (21 days) prior to the first dose of study treatment.
Have left ventricular ejection fraction (LVEF) ≥50% assessed within 28 days prior to enrollment.
Have resolution of Adverse Events (AEs), with the exception of alopecia, and of all clinically significant toxic effects of prior locoregional therapy, surgery or radiotherapy to ≤Grade 1, by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0.
Have sufficient available material from archived formalin-fixed paraffin-embedded tumor tissue for biomarker-related studies. If such tissue is not available, a newly obtained core or excisional biopsy of a tumor lesion must be performed.
If male, must be sterile or agree to use an effective method of contraception or a highly effective method of contraception during the study and for at least 12 weeks following the last dose of study treatment.
If female and of child-bearing potential, must:
Have a life expectancy of at least 3 months, in the opinion of the investigator.
Exclusion Criteria:
Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Have participated within the past 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
Have previously completed or withdrawn from any study investigating olaratumab.
Have received prior treatment with olaratumab, doxorubicin, or ifosfamide, or have participated in other trials investigating olaratumab.
Have received prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation.
Have known urinary outflow obstruction, or inflammation of the urinary bladder (cystitis).
Are diagnosed with gastrointestinal stromal tumor or Kaposi sarcoma.
Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of CNS metastasis (previously treated with curative intent [for example, stereotactic radiation or surgery]) that has not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and/or anticonvulsants are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis.
Have a history of another primary malignancy, with the exception of:
Have an active fungal, bacterial and/or known viral infection including human immunodeficiency virus or viral (A, B, or C) hepatitis (screening is not required).
Have Grade 3 or 4 peripheral neuropathy per NCI-CTCAE Version 4.0.
Have a serious cardiac condition.
Have a resting heart rate of >100 beats per minute (bpm).
Have a Fridericia's QT corrected interval (QTcF) interval of >450 milliseconds (msec) for males and >470 msec for females on screening electrocardiogram (ECG) utilizing Fridericia's correction.
Have uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics.
Have a psychiatric illness/social situation that would limit compliance with study requirements.
Have electively planned or will require major surgery during the course of the study.
Are females who are pregnant or breastfeeding.
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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 |
|---|---|---|---|---|---|---|
| University of Miami School of Medicine | Miami | Florida | 33136 | United States | ||
| University of Texas MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma | View source |
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Completers included participants who died from any cause, participants with progressive disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Participants received olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus doxorubicin 25 milligrams per meter square (mg/m^2) on days 1, 2, 3 plus ifosfamide 2.5 gram per meter square (g/m^2) per day on days 1, 2, 3, 4 plus mesna dose ≥ 60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 26, 2018 | May 12, 2020 |
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| Doxorubicin | Drug | Administered IV |
|
| Ifosfamide | Drug | Administered IV |
|
| Mesna | Drug | Administered per standard of care |
|
| PK: Maximum Serum Concentration (Cmax,ss) of Olaratumab at Steady-state | PK: Cmax of olaratumab at steady-state. | Cycle 3 - Day 1 (predose, end of infusion, 2 hours post olara, 5 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 5 hours post olara, 48 hours post olara, 168 hours post olara) |
| PK: Trough Serum Concentration (Cmin) | PK: Cmin of olaratumab. | Cycle 1 - Day 1 (predose, end of infusion, 2 hours post olaratumab (olara), 6 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 6 hours post olara, 48 hours post olara, 168 hours post olara) |
| PK: Trough Serum Concentration (Cmin,ss) of Olaratumab at Steady-state | PK: Cmin of olaratumab at steady-state. | Cycle 3 - Day 1 (predose, end of infusion, 2 hours post olara, 5 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 5 hours post olara, 48 hours post olara, 168 hours post olara) |
| Number of Participants With Anti-Olaratumab Antibodies | Participants with treatment-emergent anti-drug antibody (TE ADA) positive were 1) a participant with a 4-fold (2 dilutions) increase over a positive baseline antibody titer; or 2) for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. | Baseline through Follow-up (Up To 21 Months) |
| Objective Response Rate (ORR): Number of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) | Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. | Baseline up to Short-Term Follow-Up Period (Up To 21 Months) |
| Progression Free Survival (PFS) | Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. | Baseline to Objective Disease Progression or Death Due to Any Cause (Up To 21 Months) |
| Duration of Response (DoR) | Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment. | Date of Complete Response (CR) or Partial Response (PR) to Objective Disease Progression or Death Due to Any Cause (Up To 21 Months) |
| Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) | Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | Baseline until Disease Progression or Death Due to Any Cause (Up To 21 Months) |
| Overall Survival (OS) | Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact. | Baseline to Date of Death Due to Any Cause (Up To 21 Months) |
| Houston |
| Texas |
| 77030 |
| United States |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Università degli Studi di Catania - Azienda Policlinico | Catania | 95123 | Italy |
| FG001 | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously. |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Participants received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥ 60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously. |
| BG001 | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs) | A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the NCI-CTCAE Version 4.0:
| All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Cycle 1 (Up To 24 days) |
|
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| Secondary | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab | PK: Cmax of olaratumab. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Cycle 1 - Day 1 (predose, end of infusion, 2 hours post olaratumab (olara), 6 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 6 hours post olara, 48 hours post olara, 168 hours post olara) |
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| Secondary | PK: Maximum Serum Concentration (Cmax,ss) of Olaratumab at Steady-state | PK: Cmax of olaratumab at steady-state. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Cycle 3 - Day 1 (predose, end of infusion, 2 hours post olara, 5 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 5 hours post olara, 48 hours post olara, 168 hours post olara) |
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| Secondary | PK: Trough Serum Concentration (Cmin) | PK: Cmin of olaratumab. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Cycle 1 - Day 1 (predose, end of infusion, 2 hours post olaratumab (olara), 6 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 6 hours post olara, 48 hours post olara, 168 hours post olara) |
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| Secondary | PK: Trough Serum Concentration (Cmin,ss) of Olaratumab at Steady-state | PK: Cmin of olaratumab at steady-state. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Cycle 3 - Day 1 (predose, end of infusion, 2 hours post olara, 5 hours post olara, 24 hours post olara, 72 hours post olara), Day 8 (predose, end of infusion, 2 hours post-olara, 5 hours post olara, 48 hours post olara, 168 hours post olara) |
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| Secondary | Number of Participants With Anti-Olaratumab Antibodies | Participants with treatment-emergent anti-drug antibody (TE ADA) positive were 1) a participant with a 4-fold (2 dilutions) increase over a positive baseline antibody titer; or 2) for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20. | All participants with an evaluable baseline and at least 1 post-baseline data for Anti-Olaratumab Antibodies. | Posted | Count of Participants | Participants | No | Baseline through Follow-up (Up To 21 Months) |
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| Secondary | Objective Response Rate (ORR): Number of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) | Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline up to Short-Term Follow-Up Period (Up To 21 Months) |
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| Secondary | Progression Free Survival (PFS) | Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. | All participants who received at least one dose of study drug. Number of participants censored were Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide = 8 and Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide = 6. | Posted | Median | 95% Confidence Interval | Months | Baseline to Objective Disease Progression or Death Due to Any Cause (Up To 21 Months) |
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| Secondary | Duration of Response (DoR) | Duration of response is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1, or the date of death from any cause in the absence of objectively determined disease progression or recurrence. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment. | All participants who received at least one dose of study drug. Number of participants censored were Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide = 4 and Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide = 1. | Posted | Median | 95% Confidence Interval | Months | Date of Complete Response (CR) or Partial Response (PR) to Objective Disease Progression or Death Due to Any Cause (Up To 21 Months) |
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| Secondary | Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) | Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. | All participants who received at least one dose of study drug. | Posted | Number | Percentage of participants | Baseline until Disease Progression or Death Due to Any Cause (Up To 21 Months) |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact. | All participants who received at least one dose of study drug. Number of participants censored were Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide = 9 and Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide = 6. | Posted | Median | 95% Confidence Interval | Months | Baseline to Date of Death Due to Any Cause (Up To 21 Months) |
|
Up To 2 years
All participants who received at least one dose of study drug. There are gender specific adverse events, occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
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 | Olaratumab 15 mg/kg + Doxorubicin + Ifosfamide | Participants received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥ 60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously. | 7 | 16 | 9 | 16 | 16 | 16 |
| EG001 | Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide | Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously. | 2 | 8 | 7 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Haemodynamic instability | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Eye swelling | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA 22.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram st segment depression | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram t wave amplitude decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Hormone level abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2017 | May 12, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589393 | olaratumab |
| D004317 | Doxorubicin |
| D007069 | Ifosfamide |
| D015080 | Mesna |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
Not provided
Not provided
| 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 |
|
| Italy |
|
| Germany |
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously. |
|
|
|
|
| OG001 |
| Olaratumab 20 mg/kg + Doxorubicin + Ifosfamide |
Participants received olaratumab 20 mg/kg loading dose on days 1, 8 of cycle 1. From cycle 2, they received olaratumab 15 mg/kg on days 1, 8 plus doxorubicin 25 mg/m^2 on days 1, 2, 3 plus ifosfamide 2.5 g/m^2 per day on days 1, 2, 3, 4 plus mesna dose ≥60% of ifosfamide dose on days 1, 2, 3 of a 21-day cycle for a maximum of 6 cycles, or until a discontinuation criterion was met. All treatments were administered intravenously. |
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