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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:September 14, 2015
End Date:March 1, 2020

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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.


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).
We found this trial at
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Gary Schwartz
Phone: 646-317-6041
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Montaser Shaheen
Phone: 505-925-0404
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Scott Schuetze
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Atlanta, Georgia 30341
Principal Investigator: Gina D'Amato
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Aurora, Colorado 80045
Principal Investigator: Victor Villalobos
Phone: 720-848-0467
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Andrew Wagner
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Charlotte, North Carolina 28203
Principal Investigator: Edward Kim
Phone: 980-442-3105
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: Suzanne Partridge
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Warren Chow
Phone: 626-359-8111
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2301 Erwin Rd
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Fairfax, Virginia 22031
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3450 Hull Road
Gainesville, Florida 32608
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Germantown, Tennessee 38138
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Honolulu, Hawaii 96813
Principal Investigator: Jared Acoba
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Honolulu, Hawaii 96819
Principal Investigator: Jennifer Carney
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Neeta Somaiah
Phone: 713-792-3626
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Daniel Rushing
Phone: 317-274-3658
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Jacksonville, Florida 32216
Principal Investigator: Steven Attia
Phone: 904-953-6131
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Sarah Boles
Phone: 858-657-6746
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Arun Singh
Phone: 310-586-2095
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500 S Preston St
Louisville, Kentucky
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Principal Investigator: Vivek Sharma
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Madison, Wisconsin 53705
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Nashville, Tennessee 37203
Principal Investigator: Sarah Cannon Research Inst.
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: John Hainsworth
Phone: 615-340-2825
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: William Tap
Phone: 212-639-5908
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Omaha, Nebraska 68114
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Philadelphia, Pennsylvania 19106
Principal Investigator: Lee Hartner
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200 Lothrop St
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
Principal Investigator: Brian Van Tine
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Salt Lake City, Utah 84106
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Salt Lake City, Utah 84132
Principal Investigator: Jennifer Wright
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Spartanburg, South Carolina 29303
Principal Investigator: Melanie Thomas
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
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Tampa, Florida 33617
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