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A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma (ANNOUNCE)

Primary Purpose

Soft Tissue Sarcoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Olaratumab

Doxorubicin

Placebo

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring leiomyosarcoma, soft tissue sarcoma (STS), advanced soft tissue sarcoma, metastatic soft tissue sarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, doxorubicin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
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.

Exclusion Criteria:

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.
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).

Sites / Locations

City of Hope National Medical Center
University of California-San Diego
UCLA Medical Center
Stanford University
University of Colorado Cancer Center
University of Florida School of Medicine
Mayo Clinic of Jacksonville
Moffitt Cancer Center & Research Institute
Georgia Cancer Specialists PC
University of Hawaii Cancer Center
Kaiser Foundation Hospitals
Indiana University School of Medicine
University of Louisville
Dana Farber Cancer Institute
University of Michigan
Mayo Clinic
Washington University Medical Center
Nebraska Methodist Cancer Center
University of New Mexico Cancer Center
Columbia University
Memorial Sloan Kettering Cancer Center
Carolinas Healthcare System
Duke University Medical Center
Oncology Hematology Care Inc
Oregon Health and Science University
Pennsylvania Oncology Hematology Associates
University of Pittsburgh Medical Center
Gibbs Cancer Center
The West Clinic
SMO Sarah Cannon Research Inst.
Tennessee Oncology PLLC
Vanderbilt University Medical Center
University of Texas MD Anderson Cancer Center
Utah Cancer Specialists
University of Utah School of Medicine
Fairfax Northern Virginia Hematology Oncology, PC
University of Wisconsin-Madison Hospital and Health Clinic
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Doxorubicin + Olaratumab

Doxorubicin + Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Overall Survival (OS) Leiomyosarcoma (LMS)

Secondary Outcome Measures

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.

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.

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.

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.

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.

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).

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).

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.

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.

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).

Full Information

NCT ID

NCT02451943

First Posted

May 20, 2015

Last Updated

September 14, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02451943

Brief Title

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma

Acronym

ANNOUNCE

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 14, 2015 (Actual)

Primary Completion Date

December 5, 2018 (Actual)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Sarcoma

Keywords

leiomyosarcoma, soft tissue sarcoma (STS), advanced soft tissue sarcoma, metastatic soft tissue sarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, doxorubicin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

509 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doxorubicin + Olaratumab

Arm Type

Experimental

Arm Description

Arm Title

Doxorubicin + Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Olaratumab

Other Intervention Name(s)

LY3012207

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)

Title

Overall Survival (OS) Leiomyosarcoma (LMS)

Description

Time Frame

Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months)

Title

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)

Description

Time Frame

Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)

Title

Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)

Description

Time Frame

Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 45 Months)

Title

Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores

Description

Time Frame

Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)

Title

Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L)

Description

Time Frame

Randomization through Follow-up (Up to 35.8 Months)

Title

Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"

Description

Time Frame

Randomization through Follow-up (Up to 34.5 Months)

Title

Duration of Overall Response (DoR)

Description

Time Frame

Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 33.4 Months)

Title

Duration of Disease Control (DDC)

Description

Time Frame

Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)

Title

Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate

Description

The PK systemic clearance parameter estimates from the current analysis are listed together with the population PK model estimates.

Time Frame

Cycle 1- 9: Day 1 and 8, Predose, 5 minutes Post dose and then every other cycle and follow-up (30 Days)

Title

PK: Volume of Distribution at Steady State (Vss) of Olaratumab: Mean Parameter Estimate

Description

Time Frame

Cycle 1- 9: Day 1 and 8; Predose, 5 Minutes Post dose and then every other cycle and follow-up (30 Days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). 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. Exclusion Criteria: 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. 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope National Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010-0269

Country

United States

Facility Name

University of California-San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92037-0845

Country

United States

Facility Name

UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of Colorado Cancer Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

University of Florida School of Medicine

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Mayo Clinic of Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Moffitt Cancer Center & Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Georgia Cancer Specialists PC

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30341

Country

United States

Facility Name

University of Hawaii Cancer Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Kaiser Foundation Hospitals

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96819

Country

United States

Facility Name

Indiana University School of Medicine

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

University of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55902

Country

United States

Facility Name

Washington University Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Nebraska Methodist Cancer Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

University of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Carolinas Healthcare System

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Oncology Hematology Care Inc

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Pennsylvania Oncology Hematology Associates

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Gibbs Cancer Center

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

The West Clinic

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

SMO Sarah Cannon Research Inst.

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6307

Country

United States

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Utah Cancer Specialists

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

University of Utah School of Medicine

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Fairfax Northern Virginia Hematology Oncology, PC

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

University of Wisconsin-Madison Hospital and Health Clinic

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792-4108

Country

United States

Facility Name

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.

City

Buenos Aires

ZIP/Postal Code

1025

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2002KDS

Country

Argentina

Facility Name

City

Camperdown

ZIP/Postal Code

2050

Country

Australia

Facility Name

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Rio de Janeiro

ZIP/Postal Code

20220-410

Country

Brazil

Facility Name

City

Sao Paulo

ZIP/Postal Code

01246000

Country

Brazil

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Calgary

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

City

Edmonton

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

City

Montreal

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

City

Toronto

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

City

Vancouver

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Facility Name

City

Turku

ZIP/Postal Code

SF-20520

Country

Finland

Facility Name

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75248

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35042

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

City

Munchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

City

Tubingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

City

Tel Aviv Jaffa

ZIP/Postal Code

6423906

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

5265601

Country

Israel

Facility Name

City

Catania

ZIP/Postal Code

95125

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10060

Country

Italy

Facility Name

City

Chuo-Ku

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

City

Hidaka

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

City

Kashiwa

ZIP/Postal Code

277 8577

Country

Japan

Facility Name

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

City

Nagoya

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

537-8511

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

City

Suita-shi

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

City

Gangnam-gu

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

City

Ilsandong-gu

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

City

Seodaemun-gu

ZIP/Postal Code

120-792

Country

Korea, Republic of

Facility Name

City

Songpa-gu

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

City

Guadalajara

ZIP/Postal Code

44200

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97138

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64320

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78213

Country

Mexico

Facility Name

City

Tijuana

ZIP/Postal Code

22010

Country

Mexico

Facility Name

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

City

St Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

City

Taoyuan Hsien

ZIP/Postal Code

333

Country

Taiwan

Facility Name

City

Bebington

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Facility Name

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

City

Sheffield

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

Facility Name

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

33632930

Citation

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.

Results Reference

derived

PubMed Identifier

32259228

Citation

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.

Results Reference

derived

PubMed Identifier

28447475

Citation

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.

Results Reference

derived

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/1kxWhoB2GsgKesCo08Gmim

Description

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma

Learn more about this trial

A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma

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