A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
- Registration Number
- NCT03514407
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- 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.
- Receipt of anticancer medications, anticancer therapies, or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Must have recovered (โค Grade 2 or at pretreatment baseline) from adverse events (AEs) from previously administered therapies except for stable chronic toxicities (โค 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description INCB059872 INCB059872 INCB059872
- Primary Outcome Measures
Name Time Method Number of adverse events 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.
- Secondary Outcome Measures
Name Time Method Objective response rate 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 Up to approximately 2 weeks. Defined as maximum observed plasma concentration.
tmax of INCB059872 Up to approximately 2 weeks. Defined as time to maximum concentration.
Cl/F of INCB059872 Up to approximately 2 weeks. Defined as apparent oral dose clearance.
tยฝ of INCB059872 Up to approximately 2 weeks. Defined as apparent terminal-phase disposition half-life.
Trial Locations
- Locations (11)
UCLA Jonsson Comprehensive Cancer
๐บ๐ธLos Angeles, California, United States
Columbia University Medical Center
๐บ๐ธNew York, New York, United States
Istituto Ortopedico Rizzoli
๐ฎ๐นBologna, Italy
Ospedale Pediatrico Bambino Gesu IRCCS
๐ฎ๐นRome, Italy
Hospital Universitario Vall d'Hebron
๐ช๐ธBarcelona, Spain
Hospital Clรญnico San Carlos
๐ช๐ธMadrid, Spain
The Christie NHS Foundation Trust
๐ฌ๐งManchester, United Kingdom
Mayo Clinic Jacksonville - PPDS
๐บ๐ธJacksonville, Florida, United States
Policlinico Sant'orsola-Malpighi
๐ฎ๐นBologna, Italy
St. Jude Children's Research Hospital
๐บ๐ธMemphis, Tennessee, United States
MD Anderson Cancer Center
๐บ๐ธHouston, Texas, United States