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.
- To evaluate the safety and tolerability of INCB059872 in participants with relapsed/refractory Ewing sarcoma
- To evaluate the antitumor activity of INCB059872 in participants with relapsed/refractory Ewing sarcoma
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
Open label, Phase Ib
St. Jude Children’s Research Hospital, Memphis, Tennessee
Collaborating sites in and outside the U.S.
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.
- At least 12 years old
- Diagnosed with Ewing sarcoma that is not responsive to standard therapies
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
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
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