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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
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
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.
Time frame: Screening through 30 days after last dose of study treatment, up to approximately 6 months.
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.
Time frame: Up to approximately 6 months.
Cmax of INCB059872
Defined as maximum observed plasma concentration.
Time frame: Up to approximately 2 weeks.
tmax of INCB059872
Defined as time to maximum concentration.
Time frame: Up to approximately 2 weeks.
t½ of INCB059872
Defined as apparent terminal-phase disposition half-life.
Time frame: Up to approximately 2 weeks.
Cl/F of INCB059872
Defined as apparent oral dose clearance.
Time frame: Up to approximately 2 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 1 more locations