Soft Tissue SarcomaPhase 3ANNOUNCENCT02451943
A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
A Phase 3 study testing Olaratumab and Doxorubicin in people with Soft Tissue Sarcoma, run by Eli Lilly and Company at 114 sites in 25 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Olaratumab and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 509 participants
- Where
- 114 sitesin 25 countries
- Study dates
- 14 Sep 2015to 27 Jun 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Note: Evidence of disease progression is required for participants that are not newly diagnosed.
- Presence of measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1, Eisenhauer et al. 2009).
- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- The participant has not received any previous treatment with anthracyclines.
- The participant may have had any number of prior systemic cytotoxic therapies for advanced/metastatic disease and are considered appropriate candidates for anthracycline therapy. All previous anticancer treatments must be completed ≥ 3 weeks (21 days) prior to first dose of study drug.
- Availability of tumor tissue is required for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin embedded (FFPE) tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable).
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- Adequate hematologic, organ, and coagulation within 2 weeks (14 days) prior to randomization.
- Left ventricular ejection fraction (LVEF) ≥50% assessed within 28 days prior to randomization.
- Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
- Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug.
- The participant has, in the opinion of the investigator, a life expectancy of at least 3 months.
Who cannot join
- Diagnosis of GIST or Kaposi sarcoma.
- Active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of randomization. Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before randomization to rule out brain metastasis.
- Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial.
- Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation.
- The participant has symptomatic congestive heart failure (CHF), left ventricular dysfunction (LVEF < 50%), severe myocardial insufficiency, cardiac arrhythmia, or cardiomyopathy.
- The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of randomization.
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- The participant has a QT interval calculated using Bazett's formula (QTcB) interval of >450 milliseconds (msec) for males and >470 msec for females on screening electrocardiogram (ECG).
- Females who are pregnant or breastfeeding.
- Known allergy to any of the treatment components including a history of allergic reactions attributed to compounds of chemical or biological composition similar to olaratumab.
- The participant has a known active fungal, bacterial, or viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Trial locations and contacts
114 sites in 25 countries.
114 sites in 25 countries
United States30 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
University of Michigan
Ann Arbor, Michigan, 48109
Georgia Cancer Specialists PC
Atlanta, Georgia, 30341
University of Colorado Cancer Center
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Oncology Hematology Care Inc
Cincinnati, Ohio, 45202
Oncology Hematology Care Inc
Cincinnati, Ohio, 45211
Oncology Hematology Care Inc
Cincinnati, Ohio, 45230
Oncology Hematology Care Inc
Cincinnati, Ohio, 45236
City of Hope National Medical Center
Duarte, California, 91010-0269
Duke Cancer Institute
Durham, North Carolina, 27710
Fairfax Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, 22031
Oncology Hematology Care Inc
Fairfield, Ohio, 45014
The West Clinic
Germantown, Tennessee, 38138
Mayo Clinic in Florida
Jacksonville, Florida, 32224
UCLA Medical Center
Los Angeles, California, 90024
Oncology Hematology Care Inc
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Nebraska Methodist Cancer Center
Omaha, Nebraska, 68114
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, 19106
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Oregon Health and Science University
Portland, Oregon, 97239
Utah Cancer Specialists
Salt Lake City, Utah, 84106
University of Utah School of Medicine
Salt Lake City, Utah, 84112
Washington University Medical School
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Japan11 sites
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Okayama University Hospital
Okayama, 700-8558
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Osaka International Cancer Institute
Osaka, 541-8567
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Osaka University Hospital
Suita, Osaka, 565-0871
France7 sites
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, 69008
CHU Hopital d'enfants de la Timone
Marseille, 13385
Institut Curie
Paris, 75248
Institut Claudius Regaud
Toulouse, 31059
Gustave Roussy
Villejuif, 94805
Spain6 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Duran I Reynals
Barcelona, 08907
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen Del Rocio
Seville, Andalusia, 41013
Hospital Universitario La Fe de Valencia
Valencia, 46026
Germany5 sites
HELIOS Klinikum Berlin-Buch
Berlin, 13125
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45122
Klinikum Mannheim gGmbH Universitätsmedizin
Mannheim, Baden-Wurttemberg, 68167
Klinikum der Universität München Großhadern
München, Bavaria, 81377
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Mexico5 sites
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Centro de Atención E Investigación Clínica En Oncología
Mérida, Yucatán, 97134
Consultorio Dr. Reinoso
Monterrey, Nuevo León, 64320
Centro de Alta Especialidad Reumatologia Inv del Potosi SC
San Luis Potosí City, 78213
Hospital Angeles
Tijuana, Estado de Baja California, 22010
Netherlands5 sites
University Medical Center Groningen
Groningen, 9713 GZ
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
Maastricht UMC+
Maastricht, Limburg, 6229 HX
Universitair Medisch Centrum St Radboud Nijmegen
Nijmegen, 6525 GA
Erasmus Medisch Centrum
Rotterdam, 3015 GD
South Korea5 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Asan Medical Center
Seoul, Korea, 05505
Seoul St. Mary's Hospital
Seoul, Korea, 06591
Severance Hospital, Yonsei University Health System
Seoul, 03722
Samsung Medical Center
Seoul, 06351
United Kingdom5 sites
The Clatterbridge Cancer Centre
Bebbington, Merseyside, CH63 4JY
University College Hospital - London
London, Greater London, NW1 2BU
Royal Marsden NHS Trust
London, Greater London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
Weston Park Hospital
Sheffield, South Yorkshire, S10 2SJ
Canada4 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N4N2
Princess Margaret Hospital (Ontario)
Lai Chi Kok, Kowloon
Royal Victoria Hospital-Montreal
Montreal, Quebec, H4A 3J1
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6
Italy4 sites
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060
Università degli Studi di Catania - Azienda Policlinico
Catania, Sicily, 95123
Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Argentina3 sites
CENIT Centro de Neurociencias, Investigación y Tratamiento
Caba, Buenos Aires, C1125ABD
Alexander Fleming
CABA, BS, 1426
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS
Belgium3 sites
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
Israel3 sites
Hadassah Medical Center
Jerusalem, 9112001
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Sheba Medical Center
Tel Litwinsky, Ramat Gan, 5265601
Russia3 sites
Kazan Oncology Dispensary
Kazan', Tatarstan Republic, 420029
Blokhin Cancer Research Center
Moscow, 115478
St-Petersburg scientifical practical cente spec medical care
Saint Petersburg, 197758
Taiwan3 sites
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital - Linkou
Taoyuan Hsien, 333
Brazil2 sites
INCA Hospital do Câncer III
Rio de Janeiro, Rio de Janeiro, 20220-410
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, São Paulo, 01246-000
Finland2 sites
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, 33521
Turku University Central Hospital
Turku, SF-20520
Switzerland2 sites
Inselspital Bern
Bern, 3010
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Poland1 site
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, 02-781
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma
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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Olaratumab, Doxorubicin, Placebo
- Keywords
- leiomyosarcoma, soft tissue sarcoma (STS), advanced soft tissue sarcoma, metastatic soft tissue sarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, doxorubicin
- Medical subject headings
- Sarcoma, Leiomyosarcoma, Liposarcoma, Histiocytoma, Malignant Fibrous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaratumabDrug
Also called LY3012207
Administered IV
DoxorubicinDrug
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Olaratumab; Drug: Doxorubicin |
| 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. Receives: Drug: Doxorubicin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Cycle 1- 9: Day 1 and 8; Predose, 5 Minutes Post dose and then every other cycle and follow-up (30 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start14 Sep 2015
- Primary completion5 Dec 2018
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451943
- Sponsor's protocol ID
- 15677
- Other IDs
- I5B-MC-JGDJ, 2015-000134-30, 2015
- Acronym
- ANNOUNCE
- Status last verified
- Jun 2025
- First submitted
- 20 May 2015
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33632930Tap 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.
PubMed 32259228Tobias 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.
PubMed 28447475