A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:16 - Any
Updated:11/24/2018
Start Date:March 2, 2016
End Date:December 2020
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer
drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in
participants with advanced soft tissue sarcoma (STS) or STS that has spread to another
part(s) of the body.


Inclusion Criteria:

- The participant may have no more than 2 prior lines of systemic therapies (neoadjuvant
and adjuvant therapies will not be considered as a prior line of therapy) for advanced
or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy.
All previous therapies must have completed ≥ 3 weeks (21 days) prior to first dose of
study drug.

- In the Phase 2 part, prior olaratumab/doxorubicin combination therapy in 1 prior
treatment line is allowed.

- Prior olaratumab therapy must have been received with doxorubicin as indicated on
the olaratumab label.

- Prior olaratumab therapy must have included at least 2 full cycles of
olaratumab/doxorubicin (that is, a minimum of 4 doses of olaratumab).

- Participants, who completed at least 2 cycles of combination
olaratumab/doxorubicin therapy then discontinued doxorubicin due to toxicity or
maximum dosing and proceeded to olaratumab monotherapy, are eligible.

- The most recent dose of olaratumab must have been received within 180 days of
randomization in this study.

- Availability of tumor tissue is mandatory for study eligibility. The participant must
have consented to provide archived formalin-fixed paraffin-embedded 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).

- The participant has adequate hematologic, organ, and coagulation function within 2
weeks (14 days) prior to enrollment (Phase 1b) or randomization (Phase 2).

Exclusion Criteria:

- The participant is diagnosed with gastrointestinal stromal tumor (GIST) or Kaposi
sarcoma.

- The participant has active central nervous system (CNS) or leptomeningeal metastasis
(brain metastasis) at the time of enrollment (Phase 1b) or randomization (Phase 2).
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 enrollment (Phase 1b) /randomization (Phase 2) to rule out brain
metastasis.

- The participant has received prior treatment with gemcitabine or docetaxel. Note:
Participants previously enrolled in the I5B-MC-JGDJ (NCT02451943) or any other blinded
study with olaratumab are not eligible to participate in this trial.

- The participant has electively planned or will require major surgery during the course
of the study.

- Females who are pregnant or breastfeeding.

- The participant has an active fungal, bacterial, and/or known viral infection
including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
(screening is not required).
We found this trial at
23
sites
Aurora, Colorado 80045
Principal Investigator: Victor Villalobos
Phone: 720-848-0467
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Jade Homsi
Phone: 214-648-1579
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Vicki Leigh Keedy
Phone: 18008118480
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Lee Duncan Cranmer
Phone: 2062888220
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Adelaide, South Australia
Principal Investigator: Nimit Singhal
Phone: 6182224398
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Adelaide,
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Atlanta, Georgia 30341
Principal Investigator: Gina D'Amato
Phone: 770-496-9400
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Atlanta, GA
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: Christian Meyer
Phone: 410-340-8785
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Andrew Wagner
Phone: 617-632-5204
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Columbus, Ohio 43210
Principal Investigator: David Liebner
Phone: 614-293-3873
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Columbus, OH
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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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Jacksonville, Florida 32216
Principal Investigator: Steven Attia
Phone: 904-953-7292
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450 Lakeville Rd
Lake Success, New York 11040
(516) 734-8900
Principal Investigator: Tony Philip
Phone: 516-734-7603
Monter Cancer Center The Monter Cancer Center is a unique facility dedicated to providing state-of-the-art...
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Miami, Florida 33136
Principal Investigator: Jonathan C Trent
Phone: 305-243-0865
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: John Charlson
Phone: 404-805-4600
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Gary K Schwartz
Phone: 646-317-6041
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Mark A Dickson
Phone: 646-888-4545
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Omaha, Nebraska 68114
Principal Investigator: Kirsten Leu
Phone: 402-354-8124
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Philadelphia, Pennsylvania 19111
Principal Investigator: Sujana Movva
Phone: 215-728-2814
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Saint Louis, Missouri 63110
Principal Investigator: Brian A Van Tine
Phone: 314-747-3096
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Salt Lake City, Utah 84106
Principal Investigator: Justin A Call
Phone: 801-269-0231
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San Francisco, California 94143
Principal Investigator: Thierry M Jahan
Phone: 415-885-3882
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Santa Monica, California 90404
Principal Investigator: Bartosz Chmielowski
Phone: 310-633-8400
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Tulsa, Oklahoma 74146
Principal Investigator: Mark R Olsen
Phone: 918-505-3200
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