Relapsed Ewing SarcomaPhase 1NCT03514407
A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
A Phase 1 study testing INCB059872 in people with Relapsed Ewing Sarcoma, run by Incyte Corporation at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Relapsed Ewing Sarcoma
- What is being tested?
- INCB059872
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 27 Jun 2018to 25 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States5 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, 32224
UCLA Jonsson Comprehensive Cancer
Los Angeles, California, 90095
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Columbia University Medical Center
New York, New York, 10032
Italy3 sites
Istituto Ortopedico Rizzoli
Bologna, 40136
Policlinico Sant'orsola-Malpighi
Bologna, 40138
Ospedale Pediatrico Bambino Gesu IRCCS
Rome, 00146
Spain2 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clínico San Carlos
Madrid, 28040
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma
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.
- Conditions
- Relapsed Ewing Sarcoma
- Being tested
- INCB059872
- Keywords
- Relapsed Ewing sarcoma, bromodomain-containing protein (BRD) inhibitor, lysine demethylase 1 (LSD1) inhibitor
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| INCB059872 | Experimental | INCB059872 Receives: Drug: INCB059872 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening through 30 days after last dose of study treatment, up to approximately 6 months.
Secondary outcomes (5)
Objective response rate
Defined as the percentage of participants who have a complete response or partial response as determined by investigator assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to approximately 6 months.
Cmax of INCB059872
Defined as maximum observed plasma concentration.
Measured: Up to approximately 2 weeks.
tmax of INCB059872
Defined as time to maximum concentration.
Measured: Up to approximately 2 weeks.
t½ of INCB059872
Defined as apparent terminal-phase disposition half-life.
Measured: Up to approximately 2 weeks.
Cl/F of INCB059872
Defined as apparent oral dose clearance.
Measured: Up to approximately 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start27 Jun 2018
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Why it stopped: Strategic Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Ewing SarcomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Zheng, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514407
- Sponsor's protocol ID
- INCB 59872-103
- Other IDs
- 2018-000062-11, 2018
- Status last verified
- Oct 2025
- First submitted
- 20 Apr 2018
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma
- ClinicalTrials.gov ID
- NCT03514407
- Acronym / sponsor ID
- INCB 59872-103
- Conditions
- Relapsed Ewing Sarcoma
- Keywords
- Relapsed Ewing sarcoma, bromodomain-containing protein (BRD) inhibitor, lysine demethylase 1 (LSD1) inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic Business Decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCB059872 | Experimental | Drug: INCB059872INCB059872 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB059872Part 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. | Drug | INCB059872 |
Primary outcome
Number of adverse events
Time frame: Screening through 30 days after last dose of study treatment, up to approximately 6 months.
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.
5 secondary outcomes
Objective response rate
Time frame: Up to approximately 6 months.
Cmax of INCB059872
Time frame: Up to approximately 2 weeks.
tmax of INCB059872
Time frame: Up to approximately 2 weeks.
t½ of INCB059872
Time frame: Up to approximately 2 weeks.
Cl/F of INCB059872
Time frame: Up to approximately 2 weeks.
Results and safety
The study was stopped early (reason given: Strategic Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Zheng, MD study director
Incyte Corporation
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB059872 in people with Relapsed Ewing Sarcoma, run by Incyte Corporation at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Italy, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Screening through 30 days after last dose of study treatment, up to approximately 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.