A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma
|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
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Ewing Sarcoma||Drug: INCB059872||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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|
|Istituto Ortopedico Rizzoli|
|Bologna, Italy, 40136|
|Bologna, Italy, 40138|
|Ospedale Pediatrico Bambino Gesu IRCCS|
|Rome, Italy, 00146|
|Hospital Universitario Vall d'Hebron|
|Barcelona, Spain, 08035|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Study Director:||Fred Zheng, MD||Incyte Corporation|