A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
Stopped early · Phase 1
Conditions studied: Relapsed Ewing Sarcoma
In brief
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.
Key facts
- Study ID
- NCT03514407
- Run by
- Incyte Corporation
- People needed
- 25
- Starts
- 2018-06-27
- Expected to finish
- 2020-06-25
- Last updated by the study team
- 2025-10-21
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UCLA Jonsson Comprehensive Cancer — Los Angeles, California, United States
- Mayo Clinic Jacksonville - PPDS — Jacksonville, Florida, United States
- Columbia University Medical Center — New York, New York, United States
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Istituto Ortopedico Rizzoli — Bologna, Italy
- Policlinico Sant'orsola-Malpighi — Bologna, Italy
- Ospedale Pediatrico Bambino Gesu IRCCS — Rome, Italy
- Hospital Universitario Vall d'Hebron — Barcelona, Spain
- Hospital Clínico San Carlos — Madrid, Spain
- The Christie NHS Foundation Trust — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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