A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03514407 |
Recruitment Status :
Terminated
(Strategic Business Decision)
First Posted : May 2, 2018
Last Update Posted : July 16, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsed Ewing Sarcoma | Drug: INCB059872 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 27, 2018 |
Actual Primary Completion Date : | June 25, 2020 |
Actual Study Completion Date : | June 25, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: INCB059872
INCB059872
|
Drug: INCB059872
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. |
- 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.
- Objective response rate [ Time Frame: Up to approximately 6 months. ]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.
- Cmax of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]Defined as maximum observed plasma concentration.
- tmax of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]Defined as time to maximum concentration.
- t½ of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]Defined as apparent terminal-phase disposition half-life.
- Cl/F of INCB059872 [ Time Frame: Up to approximately 2 weeks. ]Defined as apparent oral dose clearance.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514407
United States, California | |
UCLA Jonsson Comprehensive Cancer | |
Los Angeles, California, United States, 90095 | |
United States, Florida | |
Mayo Clinic Jacksonville - PPDS | |
Jacksonville, Florida, United States, 32224 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Italy | |
Istituto Ortopedico Rizzoli | |
Bologna, Italy, 40136 | |
Policlinico Sant'orsola-Malpighi | |
Bologna, Italy, 40138 | |
Ospedale Pediatrico Bambino Gesu IRCCS | |
Rome, Italy, 00146 | |
Spain | |
Hospital Universitario Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Clínico San Carlos | |
Madrid, Spain, 28040 | |
United Kingdom | |
The Christie NHS Foundation Trust | |
Manchester, United Kingdom, M20 4BX |
Study Director: | Fred Zheng, MD | Incyte Corporation |
Responsible Party: | Incyte Corporation |
ClinicalTrials.gov Identifier: | NCT03514407 |
Other Study ID Numbers: |
INCB 59872-103 |
First Posted: | May 2, 2018 Key Record Dates |
Last Update Posted: | July 16, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Relapsed Ewing sarcoma bromodomain-containing protein (BRD) inhibitor lysine demethylase 1 (LSD1) inhibitor |
Sarcoma Sarcoma, Ewing Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Neoplasms Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue |