A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma



Status:Recruiting
Healthy:No
Age Range:12 - Any
Updated:3/17/2019
Start Date:June 27, 2018
End Date:June 2021
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma

The purpose of this study is to evaluate the safety and preliminary antitumor activity of
INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior
standard therapy and not eligible for further standard systemic therapy.


Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of Ewing sarcoma and have
progressed on or after standard therapies.

- Must not be a candidate for potentially curative therapy or standard-of-care approved
therapy.

- Measurable disease by computed tomography or magnetic resonance imaging based on
RECIST 1.1 as determined by site radiology.

- Eastern Cooperative Oncology Group performance status 0 to 2.

- Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

- Receipt of anticancer medications, anticancer therapies, or investigational drugs
within protocol-defined intervals before the first administration of study drug.

- Must have recovered (≤ Grade 2 or at pretreatment baseline) from adverse events (AEs)
from previously administered therapies except for stable chronic toxicities (≤ Grade
2) not expected to resolve.

- Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases
that have progressed.

- Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is
permitted for palliative radiation to non-CNS disease with medical monitor approval.

- Laboratory values outside the protocol-defined range at screening.

- History or evidence of bleeding disorder or active clinically significant bleeding
requiring medical intervention.
We found this trial at
6
sites
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Gary Schwartz
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Alberto Pappo
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Bologna,
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Houston, Texas 77030
Principal Investigator: Vivek Subbiah
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Houston, TX
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4500 San Pablo Road South
Jacksonville, Florida 32224
Principal Investigator: Steven Attia
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Jacksonville, FL
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Los Angeles, California 90095
Principal Investigator: Noah Federman
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Los Angeles, CA
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