INCYEWS: Study of INCB059872 for Relapsed or Refractory Ewing Sarcoma

Phase Ib Study of the Safety, Tolerability and Preliminary Antitumor Activity of INCB059872 in Participants with Relapsed or Refractory Ewing Sarcoma

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Ewing sarcoma

Eligibility Overview:

  • At least 12 years old
  • Diagnosed with Ewing sarcoma that is not responsive to standard therapies
  1. Brief Summary

    This is a Phase 1b open-label study 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.

    The standard approach to Ewing sarcoma treatment is surgery with or without radiation and chemotherapy. However, no standard treatment exists for relapsed and refractory disease.

    INCB059872 is a small-molecule selective inhibitor of lysine demethylase 1 (LSD1). Gene expression profiling and tissue microarray analysis have shown that LSD1 is highly expressed in Ewing sarcoma.

     Primary Objective

    • To evaluate the safety and tolerability of INCB059872 in participants with relapsed/refractory Ewing sarcoma

    Secondary Objective

    • To evaluate the antitumor activity of INCB059872 in participants with relapsed/refractory Ewing sarcoma

    Eligibility Criteria

    Inclusion criteria include:

    • At least 12 years old
    • Diagnosed with relapsed or refractory Ewing sarcoma
    • Available baseline archival tumor specimen or predose core tumor biopsy

    Exclusion Criteria include:

    • Received anticancer medications, anticancer therapies or investigational drugs within the protocol-defined intervals before receiving study drug:
    • Concurrent anticancer therapy
    • Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
    • Prior radiotherapy within two weeks of study treatment

    Study Design

    Open label, Phase Ib

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee
    Collaborating sites in and outside the U.S.

  2. About this study

    Ewing sarcoma is a cancerous tumor that grows in the bones or in the soft tissue around the bones. These tumors are often found in the arm, leg, pelvis or spine.

    Standard treatment for this type of cancer is chemotherapy and/or radiation therapy (treatment with high-energy rays to get rid of cancer cells). However, these treatments may only work for a short period of time or may not work at all.

    This clinical trial will evaluate the safety of an experimental drug in children and young adults with Ewing sarcoma that did not respond to other therapies or came back after treatment. This investigational drug is called INCB059872. “Investigational” means this drug has not been approved by the U.S. Food and Drug Administration (FDA).

    The study includes two parts: the screening period and the treatment period. The screening period can last from 1 to 28 days and will determine if you are eligible to participate in the study. The treatment period will test different doses of the study drug.

    Purpose of this clinical trial

    The main goal of this study is to determine the safety of INCB059872 in children and young adults with Ewing sarcoma that did not respond to standard therapies or came back after treatment. Researchers also want to learn the good and bad effects of this drug on the cancer.

    Eligibility overview

    • At least 12 years old
    • Diagnosed with Ewing sarcoma that is not responsive to standard therapies
  3. INCYEWS Quick View
    Sponsors Incyte Corporation
    ClinicalTrials.gov identifier NCT03514407
    Trial Start Date June 2018
    Estimated Enrollment 21 (2 at St. Jude)
    Study Type Interventional
    Study Phase Phase Ib
    Conditions Ewing sarcoma
    Ages 12 years and older
    Principal investigator Alberto Pappo, MD
    Study Sites St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss INCYEWS St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.