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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000062-11 | EudraCT Number |
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Strategic Business Decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB059872 | Experimental | INCB059872 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB059872 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening through 30 days after last dose of study treatment, up to approximately 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 6 months. |
| Cmax of INCB059872 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Zheng, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Jonsson Comprehensive Cancer | Los Angeles | California | 90095 | United States | ||
| Mayo Clinic Jacksonville - PPDS |
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| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| C000730036 | INCB059872 |
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Defined as maximum observed plasma concentration. |
| Up to approximately 2 weeks. |
| tmax of INCB059872 | Defined as time to maximum concentration. | Up to approximately 2 weeks. |
| t½ of INCB059872 | Defined as apparent terminal-phase disposition half-life. | Up to approximately 2 weeks. |
| Cl/F of INCB059872 | Defined as apparent oral dose clearance. | Up to approximately 2 weeks. |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| Policlinico Sant'orsola-Malpighi | Bologna | 40138 | Italy |
| Ospedale Pediatrico Bambino Gesu IRCCS | Rome | 00146 | Italy |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |