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| ID | Type | Description | Link |
|---|---|---|---|
| I5B-MC-JGDJ | Other Identifier | Eli Lilly and Company | |
| 2015-000134-30 | EudraCT Number |
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The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxorubicin + Olaratumab | Experimental | 75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21-day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21-day cycle until documented progressive disease (PD) or discontinuation for any other reason. |
|
| Doxorubicin + Placebo | Placebo Comparator | 75 mg/m^2 doxorubicin administered IV on day 1 of each 21-day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21-day cycle until PD or discontinuation for any other reason. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaratumab | Drug | Administered IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters. | Randomization to Date of Death Due to Any Cause (Up to 35.8 Months) |
| Overall Survival (OS) Leiomyosarcoma (LMS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters. | Randomization to Date of Death Due to Any Cause (Up to 35.8 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010-0269 | United States | ||
| UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33632930 | Derived | Jones RL, Wagner AJ, Kawai A, Tamura K, Shahir A, Van Tine BA, Martin-Broto J, Peterson PM, Wright J, Tap WD. Prospective Evaluation of Doxorubicin Cardiotoxicity in Patients with Advanced Soft-tissue Sarcoma Treated in the ANNOUNCE Phase III Randomized Trial. Clin Cancer Res. 2021 Jul 15;27(14):3861-3866. doi: 10.1158/1078-0432.CCR-20-4592. Epub 2021 Feb 25. | |
| 32259228 |
| Label | URL |
|---|---|
| A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Completers include participants who died in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxorubicin + Olaratumab | 75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle up to 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle thereafter until documented progressive disease (PD) or discontinuation for any other reason. |
| 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: Study Protocol | Jan 29, 2015 |
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| Doxorubicin | Drug | Administered IV |
|
| Placebo | Drug | Administered IV |
|
| Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months) |
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) | ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) + partial response (PR). CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1. | Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months) |
| Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) | DCR was defined as the percentage of randomized participants achieving a best overall response of CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PD is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.5 Months) |
| Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores | Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales [physical, role, cognitive, emotional, and social]), and 9 symptom subscales [fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale. | Randomization (Cycle 1) through Follow-up (Up to 35.8 Months) |
| Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L) | The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health status was calculated from a set of item weights to derive a score of 0 to 1, with 1 representing the best health status. United Kingdom (UK) weights were applied. The analysis includes all cycles for which at least 25% of participants in each arm have an assessment. For each participant a change from baseline was calculated for every post-baseline assessment by subtracting the baseline assessment result from the current assessment result. Maximum improvement (over baseline) was determined from the set of all post-baseline change scores. | Randomization through Follow-up (Up to 35.8 Months) |
| Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" | Time to first worsening of the brief pain inventory short form modified (mBPI-sf) "worst pain score" was defined as the time from the date of the first study drug dose (baseline date) to the first date of a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline. The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). | Randomization through Follow-up (Up to 34.5 Months) |
| Duration of Overall Response (DoR) | The duration of overall response was defined for each participant with a best response of CR or PR and measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that disease is recurrent or objective disease progression or death due to any cause is observed (taking as reference for PD the smallest measurements recorded on study). | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 33.4 Months) |
| Duration of Disease Control (DDC) | Duration of disease control was defined for each participant with a best response of CR, PR, or stable disease (SD) as the time from randomization to the first date of disease progression or death due to any cause. | Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months) |
| Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate | The PK systemic clearance parameter estimates from the current analysis are listed together with the population PK model estimates. | Cycle 1- 9: Day 1 and 8, Predose, 5 minutes Post dose and then every other cycle and follow-up (30 Days) |
| PK: Volume of Distribution at Steady State (Vss) of Olaratumab: Mean Parameter Estimate | The PK parameter estimates from the current analysis are listed together with the population PK model estimates. The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2). | Cycle 1- 9: Day 1 and 8; Predose, 5 Minutes Post dose and then every other cycle and follow-up (30 Days) |
| Los Angeles |
| California |
| 90024 |
| United States |
| Stanford University | Stanford | California | 94305 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
| Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Georgia Cancer Specialists PC | Atlanta | Georgia | 30341 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University Medical School | St Louis | Missouri | 63110 | United States |
| Nebraska Methodist Cancer Center | Omaha | Nebraska | 68114 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45202 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45211 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45230 | United States |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45236 | United States |
| Oncology Hematology Care Inc | Fairfield | Ohio | 45014 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Pennsylvania Oncology Hematology Associates | Philadelphia | Pennsylvania | 19106 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| The West Clinic | Germantown | Tennessee | 38138 | United States |
| Oncology Hematology Care Inc | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-6307 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| University of Utah School of Medicine | Salt Lake City | Utah | 84112 | United States |
| Fairfax Northern Virginia Hematology Oncology, PC | Fairfax | Virginia | 22031 | United States |
| Alexander Fleming | CABA | BS | 1426 | Argentina |
| CENIT Centro de Neurociencias, Investigación y Tratamiento | Caba | Buenos Aires | C1125ABD | Argentina |
| Hospital Provincial del Centenario | Rosario | Santa Fe Province | S2002KDS | Argentina |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| AKH | Vienna | 1090 | Austria |
| Cliniques universitaires Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| INCA Hospital do Câncer III | Rio de Janeiro | Rio de Janeiro | 20220-410 | Brazil |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | São Paulo | 01246-000 | Brazil |
| Tom Baker Cancer Center | Calgary | Alberta | T2N4N2 | Canada |
| BC Cancer Vancouver | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Hospital (Ontario) | Lai Chi Kok | Kowloon | Canada |
| Royal Victoria Hospital-Montreal | Montreal | Quebec | H4A 3J1 | Canada |
| Herlev and Gentofte Hospital | Herlev | 2730 | Denmark |
| Tampereen yliopistollinen sairaala | Tampere | Pirkanmaa | 33521 | Finland |
| Turku University Central Hospital | Turku | SF-20520 | Finland |
| Centre Leon Berard | Lyon | Auvergne-Rhône-Alpes | 69008 | France |
| Centre Georges François Leclerc | Dijon | Côte-d'Or | 21079 | France |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | 33076 | France |
| CHU Hopital d'enfants de la Timone | Marseille | 13385 | France |
| Institut Curie | Paris | 75248 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Klinikum Mannheim gGmbH Universitätsmedizin | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Universitätsklinikum Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Klinikum der Universität München Großhadern | München | Bavaria | 81377 | Germany |
| Universitaetsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | 1062 | Hungary |
| Sheba Medical Center | Tel Litwinsky | Ramat Gan | 5265601 | Israel |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Università degli Studi di Catania - Azienda Policlinico | Catania | Sicily | 95123 | Italy |
| Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia | Candiolo | Torino | 10060 | Italy |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Saitama Medical University International Medical Center | Hidaka | Saitama | 350-1298 | Japan |
| National Cancer Center Hospital | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Japanese Foundation for Cancer Research | Koto-ku | Tokyo | 135-8550 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Hospital Angeles | Tijuana | Estado de Baja California | 22010 | Mexico |
| Hospital Civil Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
| Consultorio Dr. Reinoso | Monterrey | Nuevo León | 64320 | Mexico |
| Centro de Atención E Investigación Clínica En Oncología | Mérida | Yucatán | 97134 | Mexico |
| Centro de Alta Especialidad Reumatologia Inv del Potosi SC | San Luis Potosí City | 78213 | Mexico |
| Maastricht UMC+ | Maastricht | Limburg | 6229 HX | Netherlands |
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | 2333 ZA | Netherlands |
| Universitair Medisch Centrum St Radboud Nijmegen | Nijmegen | 6525 GA | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 GD | Netherlands |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Kazan Oncology Dispensary | Kazan' | Tatarstan Republic | 420029 | Russia |
| Blokhin Cancer Research Center | Moscow | 115478 | Russia |
| St-Petersburg scientifical practical cente spec medical care | Saint Petersburg | 197758 | Russia |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Asan Medical Center | Seoul | Korea | 05505 | South Korea |
| Seoul St. Mary's Hospital | Seoul | Korea | 06591 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario Virgen Del Rocio | Seville | Andalusia | 41013 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Duran I Reynals | Barcelona | 08907 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Fe de Valencia | Valencia | 46026 | Spain |
| Skånes universitetssjukhus Lund | Lund | 22185 | Sweden |
| Cantonal Hospital St.Gallen | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital - Linkou | Taoyuan Hsien | 333 | Taiwan |
| University College Hospital - London | London | Greater London | NW1 2BU | United Kingdom |
| Royal Marsden NHS Trust | London | Greater London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| The Clatterbridge Cancer Centre | Bebbington | Merseyside | CH63 4JY | United Kingdom |
| Weston Park Hospital | Sheffield | South Yorkshire | S10 2SJ | United Kingdom |
| Tap WD, Wagner AJ, Schoffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Papai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. doi: 10.1001/jama.2020.1707. |
| 28447475 | Derived | Tobias A, O'brien MP, Agulnik M. Olaratumab for advanced soft tissue sarcoma. Expert Rev Clin Pharmacol. 2017 Jul;10(7):699-705. doi: 10.1080/17512433.2017.1324295. Epub 2017 May 5. |
| FG001 | Doxorubicin + Placebo | 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle up to 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle thereafter until PD or discontinuation for any other reason. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Doxorubicin + Olaratumab | 75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason. |
| BG001 | Doxorubicin + Placebo | 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. |
| 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 |
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| 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 |
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| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters. | All randomized participants. Censored participants in Doxorubicin + Olaratumab arm = 87 and Doxorubicin + Placebo arm = 91 | Posted | Median | 95% Confidence Interval | Months | Randomization to Date of Death Due to Any Cause (Up to 35.8 Months) |
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| Primary | Overall Survival (OS) Leiomyosarcoma (LMS) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters. | All randomized participants with LMS. Censored participants in Doxorubicin + Olaratumab arm = 42 and Doxorubicin + Placebo arm = 40. | Posted | Median | 95% Confidence Interval | Months | Randomization to Date of Death Due to Any Cause (Up to 35.8 Months) |
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| Secondary | Progression Free Survival (PFS) | PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression. | All randomized participants. Censored participants in the Doxorubicin + Olaratumab arm = 39 and the Doxorubicin + Placebo arm =34. | Posted | Median | 95% Confidence Interval | Months | Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months) |
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| Secondary | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) | ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) + partial response (PR). CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1. | All randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months) |
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| Secondary | Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR) | DCR was defined as the percentage of randomized participants achieving a best overall response of CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PD is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | All randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.5 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores | Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales [physical, role, cognitive, emotional, and social]), and 9 symptom subscales [fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale. | All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period. | Posted | Median | 95% Confidence Interval | Months | Randomization (Cycle 1) through Follow-up (Up to 35.8 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L) | The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health status was calculated from a set of item weights to derive a score of 0 to 1, with 1 representing the best health status. United Kingdom (UK) weights were applied. The analysis includes all cycles for which at least 25% of participants in each arm have an assessment. For each participant a change from baseline was calculated for every post-baseline assessment by subtracting the baseline assessment result from the current assessment result. Maximum improvement (over baseline) was determined from the set of all post-baseline change scores. | All randomized participants who had a baseline and a post-baseline measurement. | Posted | Mean | Standard Deviation | score on a scale | Randomization through Follow-up (Up to 35.8 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" | Time to first worsening of the brief pain inventory short form modified (mBPI-sf) "worst pain score" was defined as the time from the date of the first study drug dose (baseline date) to the first date of a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline. The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). | All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period. | Posted | Median | 95% Confidence Interval | Months | Randomization through Follow-up (Up to 34.5 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Response (DoR) | The duration of overall response was defined for each participant with a best response of CR or PR and measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that disease is recurrent or objective disease progression or death due to any cause is observed (taking as reference for PD the smallest measurements recorded on study). | All randomized participants who have evaluable DoR data. | Posted | Median | 95% Confidence Interval | Months | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 33.4 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Disease Control (DDC) | Duration of disease control was defined for each participant with a best response of CR, PR, or stable disease (SD) as the time from randomization to the first date of disease progression or death due to any cause. | All randomized participants who had evaluable DDC data. | Posted | Median | 95% Confidence Interval | Months | Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate | The PK systemic clearance parameter estimates from the current analysis are listed together with the population PK model estimates. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | 95% Confidence Interval | Liter/hour (L/h) | Cycle 1- 9: Day 1 and 8, Predose, 5 minutes Post dose and then every other cycle and follow-up (30 Days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK: Volume of Distribution at Steady State (Vss) of Olaratumab: Mean Parameter Estimate | The PK parameter estimates from the current analysis are listed together with the population PK model estimates. The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2). | All randomized participants who had received at least one dose of study drug and had evaluable PK data. | Posted | Mean | 95% Confidence Interval | Liter (L) | Cycle 1- 9: Day 1 and 8; Predose, 5 Minutes Post dose and then every other cycle and follow-up (30 Days) |
|
|
Baseline Up To 41 Months
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatments the participants received.
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 | Doxorubicin + Olaratumab | 75 milligrams per meter squared (mg/m^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason. | 170 | 257 | 105 | 257 | 248 | 257 |
| EG001 | Doxorubicin + Placebo | 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. | 158 | 249 | 89 | 249 | 244 | 249 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sciatic nerve neuropathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vertebrobasilar artery dissection | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Sep 27, 2019 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Study Protocol (d) | Jan 12, 2017 | Sep 27, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2018 | Sep 27, 2019 | SAP_002.pdf |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D007890 | Leiomyosarcoma |
| D008080 | Liposarcoma |
| D051677 | Histiocytoma, Malignant Fibrous |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009379 | Neoplasms, Muscle Tissue |
| D018205 | Neoplasms, Adipose Tissue |
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
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
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Russia |
|
| Austria |
|
| South Korea |
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| Netherlands |
|
| Sweden |
|
| Brazil |
|
| Poland |
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| France |
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| Argentina |
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| Hungary |
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| Japan |
|
| United Kingdom |
|
| Switzerland |
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| Spain |
|
| Canada |
|
| Belgium |
|
| Finland |
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| Taiwan |
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| Denmark |
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| Italy |
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| Mexico |
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| Israel |
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| Australia |
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| Germany |
|
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. |
|
|
|
| OG001 | Doxorubicin + Placebo | 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. |
|
|
|
| Doxorubicin + Placebo |
75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. |
|
|
| OG001 | Doxorubicin + Placebo | 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. |
|
|
| OG001 | Doxorubicin + Placebo | 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. |
|
|
| OG001 | Doxorubicin + Placebo | 75 mg/m^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason. |
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| Units | Counts |
|---|---|
| Participants |
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