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| ID | Type | Description | Link |
|---|---|---|---|
| I5B-JE-JGDK | Other Identifier | Eli Lilly and Company |
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This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate safety and side effects of olaratumab in combination with doxorubicin in Japanese participants with a group of rare cancers (advanced solid tumors, especially advanced soft tissue sarcoma [STS].) The main purpose of Part B is to evaluate how much olaratumab gets into the blood stream of Japanese participants with advanced solid tumors and how long it takes the body to get rid of it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A cohort 1: Olaratumab+Doxorubicin | Experimental | 15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met . |
|
| Part A cohort 2: Olaratumab+Doxorubicin | Experimental | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
|
| Part A cohort 3 Olaratumab + Doxorubicin | Experimental | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaratumab | Biological | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Baseline to Study completion (Up To 3.5 Years) |
| Part A: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 21) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section. | Cycle 1 (21 Days) |
| Part B: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab | Maximum observed serum concentration (Cmax) of olaratumab is reported. | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
| Part B: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab | AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported. | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab | Maximum observed serum concentration (Cmax) of olaratumab is reported. | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
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Inclusion Criteria:
Part A: Have histological or cytological evidence of a diagnosis of advanced or metastatic solid tumor, especially STS, which is not amenable to treatment with surgery or radiotherapy. Part B: Have histological or cytological evidence of a diagnosis of solid tumor that is advanced or metastatic.
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Have given written informed consent prior to any study-specific procedures.
Have adequate organ and coagulation function
Have an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of less than or equal to 1.
Have discontinued previous treatments for cancer and recovered from the acute effects of therapy.
(Part A only) Have a prestudy echocardiogram with an actual left ventricular ejection fraction greater than or equal to 50%, within 21 days prior to first dose of study medication.
All participants agree to use a reliable method of birth control and to not donate sperm during the study and for at least 3 months following last dose of study drug.
Female participants:
Have an estimated life expectancy of more than or equal to 3 months in the judgment of the investigator.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Chūōku | 104-0045 |
Participants were considered to have competed the study if the study discontinued due to adverse event, progressive disease (PD) or withdrawal by subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A Cohort 1: Olaratumab+Doxorubicin | 15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met |
| FG001 | Part A Cohort 2: Olaratumab+Doxorubicin | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| FG002 | Part A Cohort 3 Olaratumab + Doxorubicin | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| FG003 | Part B: Olaratumab | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A and Part B.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A Cohort 1: Olaratumab+Doxorubicin | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A. | Posted | Number | participants | Baseline to Study completion (Up To 3.5 Years) |
|
Baseline to Study completion (Up To 3.5 Years)
All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A and Part B.
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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 | Part A Cohort 1: Olaratumab+Doxorubicin | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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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 | Sep 28, 2018 | Aug 12, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2015 | Aug 12, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000589393 | olaratumab |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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Not provided
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| Part B: Olaratumab | Experimental | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
|
|
| Doxorubicin | Drug | Administered IV |
|
| Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab | AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported. | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
| Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin | Maximum observed plasma concentration (Cmax) of doxorubicin is reported. | Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3, Cycle 3 Day 1, Cycle 3 Day 2 and Cycle 3 Day 3: Immediately postinfusion |
| Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin | Maximum observed plasma concentration (Cmax) of doxorubicin is reported. | Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion |
| Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Doxorubicin | Area under the concentration verses time curve from zero to infinity (AUC[0-∞]) of doxorubicin is reported. | Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion |
| Change From Baseline in Percentage of Participants With a Tumor Response | Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is greater than or equal to (≥) 30% decrease in sum of longest diameter of target lesions. | Baseline to Study completion (Up To 3.5 Years) |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Kōtoku | 135-8550 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Nagoya | 466-8560 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician. | Suita-shi | 565-0871 | Japan |
| BG001 | Part A Cohort 2: Olaratumab+Doxorubicin | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| BG002 | Part A Cohort 3 Olaratumab + Doxorubicin | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| BG003 | Part B: Olaratumab | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | Part A Cohort 2: Olaratumab+Doxorubicin | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| OG002 | Part A Cohort 3 Olaratumab + Doxorubicin | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
|
|
| Primary | Part A: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 21) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section. | All enrolled patients who completed Cycle 1 (initial 21-day treatment period), or who discontinued due to DLT during Cycle 1 in Part A. | Posted | Count of Participants | Participants | No | Cycle 1 (21 Days) |
|
|
|
| Primary | Part B: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab | Maximum observed serum concentration (Cmax) of olaratumab is reported. | All enrolled participants who received any amount of study drug (olaratumab) and had evaluable pharmacokinetics (PK) data in Part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
|
|
|
| Primary | Part B: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab | AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported. | All enrolled participants who received any amount of study drug (olaratumab) and had evaluable PK data in Part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/mL (μg*h/mL) | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
|
|
|
| Secondary | Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab | Maximum observed serum concentration (Cmax) of olaratumab is reported. | All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
|
|
|
| Secondary | Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab | AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported. | All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter (μg*h/mL) | Cycle (C) 1 Day (D) 1 and C3 D1: Pre-infusion, Immediately postinfusion and 1.5, 24, 48, 72 and 168 hours (h) postinfusion; C1 D8 and C3 D8: Pre- infusion, Immediately postinfusion and 1, 48, 72, 168 and 336 h postinfusion |
|
|
|
| Secondary | Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin | Maximum observed plasma concentration (Cmax) of doxorubicin is reported. | All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL | Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3, Cycle 3 Day 1, Cycle 3 Day 2 and Cycle 3 Day 3: Immediately postinfusion |
|
|
|
| Secondary | Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin | Maximum observed plasma concentration (Cmax) of doxorubicin is reported. | All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion |
|
|
|
| Secondary | Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Doxorubicin | Area under the concentration verses time curve from zero to infinity (AUC[0-∞]) of doxorubicin is reported. | All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. AUC data is not available for Part A cohort 1 as PK was evaluated immediately post infusion of doxorubicin in Part A cohort 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/mL (ng*h/mL) | Cycle 1 Day 1 and Cycle 3 Day 1: Immediately postinfusion, 0.5, 1, 2, 4, 8, 24, 48, and 72 h postinfusion |
|
|
|
| Secondary | Change From Baseline in Percentage of Participants With a Tumor Response | Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is greater than or equal to (≥) 30% decrease in sum of longest diameter of target lesions. | All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A and Part B. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Study completion (Up To 3.5 Years) |
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| 7 |
| 7 |
| EG001 | Part A Cohort 2: Olaratumab+Doxorubicin | 15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 0 | 6 | 4 | 6 | 6 | 6 |
| EG002 | Part A Cohort 3 Olaratumab + Doxorubicin | 20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG003 | Part B: Olaratumab | 15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met. | 0 | 6 | 2 | 6 | 5 | 6 |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vascular pain | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vasculitis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Principal investigators are fully restricted to publish any results of the study without sponsor's permission.
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
|
| Cycle 3 Day 1 |
|
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| Cycle 3 Day 8 |
|
|
|
| Cycle 3 Day 1: AUC(0-168h) |
|
|
| Cycle 3 Day 8: AUC(0-336h) |
|
|
| Cycle 1 Day 8 |
|
|
| Cycle 3 Day 1 |
|
|
| Cycle 3 Day 8 |
|
|
| Cycle 1 Day 8: AUC(0-336h) |
|
|
| Cycle 3 Day 1: AUC(0-168h) |
|
|
| Cycle 3 Day 8: AUC(0-336h) |
|
|
|
| Cycle 1 Day 3 |
|
|
| Cycle 3 Day 1 |
|
|
| Cycle 3 Day 2 |
|
|
| Cycle 3 Day 3 |
|
|
| Cycle 3 Day 1 |
|
|
| Cycle 3 Day 1 |
|
|