A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma

Status: Active

Description

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.

Eligibility Criteria

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.

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: In review
Contact: Amanda Gonzalez
Phone: 310-206-5130
Email: amgonzalez@mednet.ucla.edu

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Tennessee

Memphis
St. Jude Children's Research Hospital
Status: Approved
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Corporation

Trial IDs

Primary ID INCB 59872-103
Secondary IDs NCI-2018-01504
Clinicaltrials.gov ID NCT03514407