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 (≤ 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.
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.
t½ of INCB059872 Up to approximately 2 weeks. Defined as apparent terminal-phase disposition half-life.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (11)
UCLA Jonsson Comprehensive Cancer
🇺🇸Los Angeles, California, United States
Mayo Clinic Jacksonville - PPDS
🇺🇸Jacksonville, Florida, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy
Policlinico Sant'orsola-Malpighi
🇮🇹Bologna, Italy
Ospedale Pediatrico Bambino Gesu IRCCS
🇮🇹Rome, Italy
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Scroll for more (1 remaining)UCLA Jonsson Comprehensive Cancer🇺🇸Los Angeles, California, United States