Clinical trial NCT03514407: A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Relapsed Ewing Sarcoma
Keywords: Relapsed Ewing sarcoma
bromodomain-containing protein (BRD) inhibitor
lysine demethylase 1 (LSD1) inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-05-02
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events
timeFrame: Screening through 30 days after last dose of study treatment, up to approximately 6 months.
Secondary outcomes:
measure: Objective response rate
timeFrame: Up to approximately 6 months.
measure: Cmax of INCB059872
timeFrame: Up to approximately 2 weeks.
measure: tmax of INCB059872
timeFrame: Up to approximately 2 weeks.
measure: t½ of INCB059872
timeFrame: Up to approximately 2 weeks.
measure: Cl/F of INCB059872
timeFrame: Up to approximately 2 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville - PPDS
state: Florida
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Bologna
country: Italy
facility: Policlinico Sant'orsola-Malpighi
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesu IRCCS
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Incyte Corporation
name: Fred Zheng, MD
role: STUDY_DIRECTOR
References: