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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03514407|
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Ewing Sarcoma||Drug: INCB059872||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 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|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
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
|Contact: Incyte Corporation Call Center (US)||email@example.com|
|Contact: Incyte Corporation Call Center (ex-US)||+800 firstname.lastname@example.org|
|United States, California|
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|Los Angeles, California, United States, 90095|
|Principal Investigator: Noah Federman|
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|Jacksonville, Florida, United States, 32224|
|Principal Investigator: Steven Attia|
|United States, New York|
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|Bologna, Italy, 00146|
|Principal Investigator: Giuseppe Milano|
|Policlinico Sant'orsola-Malpighi||Not yet recruiting|
|Bologna, Italy, 40138|
|Principal Investigator: Stefania Salvagni|
|Hospital Universitario Vall d'Hebron||Recruiting|
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|Principal Investigator: Claudia Valverde Morales|
|Hospital Clínico San Carlos||Recruiting|
|Madrid, Spain, 28040|
|Principal Investigator: Antonio Casado|
|The Christie NHS Foundation Trust||Not yet recruiting|
|Manchester, United Kingdom, M20 4BX|
|Principal Investigator: Martin McCabe|
|Study Director:||Fred Zheng, MD||Incyte Corporation|