Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5B-MC-JGDM | Other Identifier | Eli Lilly and Company | |
| 2015-005018-31 | EudraCT Number |
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The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olaratumab + Doxorubicin | Experimental | Cycle 1: Olaratumab 20 milligram per kilogram (mg/kg) given intravenously (IV) on Day 1 and Day 8 (21 day cycle). Cycle 2: Olaratumab 20 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycle). Cycle 3 through Cycle 7: Olaratumab 15 mg/kg given IV on Day 1 and Day 8 plus doxorubicin 75 mg/m2 given IV on Day 1 (21 day cycles). |
|
| Olaratumab + Radiotherapy Addendum | Experimental | Olaratumab given IV on Day 1 and Day 8 (21 day cycle) concurrently with radiotherapy. Radiotherapy addendum was not implemented. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaratumab | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood | Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously. | Baseline, End of Cycle 1 (21 days) |
| Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue | Over-activity of PDGF signaling is associated with the development of certain malignant diseases. Olaratumab is an IgG1 antagonist of PDGFRα. | Baseline, End of Cycle 1 (21 days) |
| Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue | PDGF A, PDGF B, PDGF C, and PDGF D are platelet-derived growth factor canonical ligands associated with activation of PDGFR α and β. | Baseline, End of Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression-free survival (PFS) is defined as the time from the date of first study dose to the first date of radiologic disease progression or death due to any cause. Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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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 |
|---|---|---|---|---|---|---|
| USC/Norris Comp Cancer Center | Los Angeles | California | 90033 | United States | ||
| Yale University School of Medicine |
Not provided
| Label | URL |
|---|---|
| Click here for more information about this study: A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma | View source |
Not provided
Not provided
Participants are considered to have completed the study if they completed one cycle of monotherapy and all 6 cycles of combination therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Olaratumab + Doxorubicin | Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8 followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin. Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1. Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2017 | Jun 11, 2019 |
Not provided
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| Doxorubicin | Drug | Administered IV |
|
| External Beam Radiotherapy | Radiation |
|
| Baseline to Objective Progression or Death from Any Cause (Up to 18 Months) |
| Objective Response Rate (ORR): Percent of Participants With Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) | Overall Response Rate (ORR) is defined as the percentage of participants achieving a best overall response of either Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. The best overall response is the best response from the start of the treatment until progressive disease (PD)/recurrence. | Baseline to Measured Progressive Disease (Up to 18 Months) |
| Disease Control Rate (DCR): Percent of Participants Who Exhibit Stable Disease (SD), CR or PR | Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD. Participants who do not have any post-baseline tumor response assessments for any reason are considered non-responders and are included in the denominator when calculating the response rate. | Baseline to Measured Progressive Disease (Up to 18 Months) |
| Percentage of Participants With Resectable Tumors (Resectability Rate) | Resectability rate is obtained when the total number of participants with resectable tumors is divided by the total number of participants. Resectability of a tumor is determined by the surgeon and multi-disciplinary team and dependent on tumor stage and the participants coexisting medical conditions. | Cycle 1 through Cycle 7 (Up to 6 Months) |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy | Summary of Cmax of olaratumab monotherapy on Cycle 1 Day 1 and Day 8 | Cycle 1 Days 1 and 8: Predose; 5 minutes(m) post-infusion |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab | Cmax of olaratumab Cycles 2 and 3 Day 1 and 8 of a 21-day cycle. | Cycle 2 Day 1: Predose, 5 minutes(m) post-infusion, 24 hours(h), 96h; Day 8:Predose, 5 m, and 24h, 48h, 96h, and 240h postdose; Cycle 3 Day 1 and Day 8: Predose and 5m post-infusion |
| Number of Participants With Anti-Olaratumab Antibodies | A participant is counted as positive if they had at least one anti-olaratumab antibody positive result during the study. | Predose Cycle 1 Day 1 through Follow-Up (Up to 8 Months) |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Moffitt Cancer Center & Research Inst | Tampa | Florida | 33612 | United States |
| Kansas City Cancer Center | Overland Park | Kansas | 66210 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Levine Children's Hospital | Charlotte | North Carolina | 28203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| 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. | Lyon | 69373 | France |
| 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. | Milan | 20133 | Italy |
| 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. | Barcelona | 08025 | Spain |
| 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. | Seville | 41013 | Spain |
| 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. | London | SW3 6JJ | United Kingdom |
| Received At Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olaratumab + Doxorubicin | Cycle 1: olaratumab 20 mg/kg administered intravenously IV on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin. Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1. Cycle 3-7: olaratumab 15 mg/kg administered IV on Day 1 and Day 8 and doxorubicin 75 mg/m2 IV on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||||
| Circulating Tumor Cells (CTC) | All participants who received at least one dose of study drug and had evaluable blood samples for CTCs at baseline. | Mean | Standard Deviation | CTC per milliliter |
| ||||||||||||||||
| Platelet-Derived Growth Factor Receptor Alpha (PGDFRα ) and PGDFR Beta (β) | All participants who received at least one dose of study drug and had evaluable tissue samples at baseline. | Mean | Standard Deviation | relative gene expression units |
| ||||||||||||||||
| PDGF Canonical Ligands -A, -B, -C, -D | All participants who received at least one dose of study drug and had evaluable tissue samples at baseline. | Mean | Standard Deviation | relative gene expression units |
|
| 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 | Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood | Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously. | All participants who received one cycle of study drug and had evaluable blood samples for CTCs at baseline and post-olaratumab monotherapy. | Posted | Mean | Standard Deviation | percent change | Baseline, End of Cycle 1 (21 days) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue | Over-activity of PDGF signaling is associated with the development of certain malignant diseases. Olaratumab is an IgG1 antagonist of PDGFRα. | All participants who received at least one dose of study drug and had evaluable tissue samples at baseline and post-olaratumab monotherapy. | Posted | Mean | Standard Deviation | percent change in gene expression | Baseline, End of Cycle 1 (21 days) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue | PDGF A, PDGF B, PDGF C, and PDGF D are platelet-derived growth factor canonical ligands associated with activation of PDGFR α and β. | All participants who received at least one dose of study drug and had evaluable baseline tissue samples at baseline and post-olaratumab monotherapy. | Posted | Mean | Standard Deviation | percent change in gene expression | Baseline, End of Cycle 1 (21 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Progression-free survival (PFS) is defined as the time from the date of first study dose to the first date of radiologic disease progression or death due to any cause. Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression. | All participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | months | Baseline to Objective Progression or Death from Any Cause (Up to 18 Months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR): Percent of Participants With Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) | Overall Response Rate (ORR) is defined as the percentage of participants achieving a best overall response of either Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. The best overall response is the best response from the start of the treatment until progressive disease (PD)/recurrence. | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline to Measured Progressive Disease (Up to 18 Months) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR): Percent of Participants Who Exhibit Stable Disease (SD), CR or PR | Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD. Participants who do not have any post-baseline tumor response assessments for any reason are considered non-responders and are included in the denominator when calculating the response rate. | All participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline to Measured Progressive Disease (Up to 18 Months) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Resectable Tumors (Resectability Rate) | Resectability rate is obtained when the total number of participants with resectable tumors is divided by the total number of participants. Resectability of a tumor is determined by the surgeon and multi-disciplinary team and dependent on tumor stage and the participants coexisting medical conditions. | All participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 through Cycle 7 (Up to 6 Months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy | Summary of Cmax of olaratumab monotherapy on Cycle 1 Day 1 and Day 8 | 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 Days 1 and 8: Predose; 5 minutes(m) post-infusion |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab | Cmax of olaratumab Cycles 2 and 3 Day 1 and 8 of a 21-day cycle. | 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 2 Day 1: Predose, 5 minutes(m) post-infusion, 24 hours(h), 96h; Day 8:Predose, 5 m, and 24h, 48h, 96h, and 240h postdose; Cycle 3 Day 1 and Day 8: Predose and 5m post-infusion |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Olaratumab Antibodies | A participant is counted as positive if they had at least one anti-olaratumab antibody positive result during the study. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Predose Cycle 1 Day 1 through Follow-Up (Up to 8 Months) |
|
|
Baseline to end of study (Up to 46 months)
All participants who received at least one dose of study drug.
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 + Doxorubicin | Cycle 1: olaratumab 20 mg/kg administered intravenously (IV) on Day 1 and Day 8, followed by up to 6 cycles (Cycle 2 - Cycle 7) of combination therapy with olaratumab and doxorubicin. Cycle 2: olaratumab 20 mg/kg administered IV on Day 1 and Day 8 and 75 mg/m2 of doxorubicin IV on Day 1. Cycle 3-7: olaratumab15mg/kg administered IV on Day 1 and Day 8 and 75 mg/m2 of doxorubicin IV on Day 1. | 3 | 51 | 22 | 51 | 50 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Guillain-barre syndrome | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
Radiotherapy addendum was not implemented due to business decisions. There were no safety or efficacy issues related to the addendum that contributed to this decision.
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 | Jul 20, 2017 | Jun 11, 2019 | 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 |
| 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 |
Not provided
Not provided
| >=65 years |
|
|
| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| United Kingdom |
|
|
| France |
|
|
| Spain |
|
|
| All Population CTC |
|
|
| PGDFRβ |
|
|
| PDGF-B |
|
|
| PDGF-C |
|
|
| PDGF-D |
|
|
|
|
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cycle 1 Day 1 |
|
| ||||
| Cycle 1 Day 8 |
|
|
|
|