NCT03514407

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2018

Typical duration for phase_1

Geographic Reach
4 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

April 20, 2018

Last Update Submit

October 20, 2025

Conditions

Relapsed Ewing Sarcoma

Keywords

Relapsed Ewing sarcomabromodomain-containing protein (BRD) inhibitorlysine demethylase 1 (LSD1) inhibitor

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    Defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a drug in humans, whether or not considered drug-related.

    Screening through 30 days after last dose of study treatment, up to approximately 6 months.

Secondary Outcomes (5)

  • Objective response rate

    Up to approximately 6 months.

  • Cmax of INCB059872

    Up to approximately 2 weeks.

  • tmax of INCB059872

    Up to approximately 2 weeks.

  • t½ of INCB059872

    Up to approximately 2 weeks.

  • Cl/F of INCB059872

    Up to approximately 2 weeks.

Study Arms (1)

INCB059872

EXPERIMENTAL

INCB059872

Drug: INCB059872

Interventions

INCB059872DRUG

Part 1: Initial cohort of INCB059872 administered every other day (QOD) at the protocol-defined starting dose, with subsequent cohort dose escalation based on protocol-defined criteria. Part 2: Expansion with the recommended dose from Part 1.

INCB059872

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UCLA Jonsson Comprehensive Cancer

Los Angeles, California, 90095, United States

Location

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, 32224, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Policlinico Sant'orsola-Malpighi

Bologna, 40138, Italy

Location

Ospedale Pediatrico Bambino Gesu IRCCS

Rome, 00146, Italy

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Sarcoma, Ewing

Interventions

INCB059872

Condition Hierarchy (Ancestors)

OsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Study Officials

  • Fred Zheng, MD

    Incyte Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 2, 2018

Study Start

June 27, 2018

Primary Completion

June 25, 2020

Study Completion

June 25, 2020

Last Updated

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)IT(3)US(5)ES(2)