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This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.
An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB024360 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB024360 | Drug | INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by adverse events and dose limiting toxicities | Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter) |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor assessment as measured by RECIST criteria | Measured from baseline through treatment cessation. (Measured every other cycle and end of study) | |
| Measurement of IDO inhibition in whole blood measured through blood sampling. | Cycle 1, Day 1 and each 28 day subsequent cycle at Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lance Leopold, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago | Illinois | United States | ||||
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000613752 | epacadostat |
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| PK analysis | Full PK at Days 1, 8 (trough only), 15 at Cycle 1 and trough at each subsequent cycle at Day 1 |
| Philadelphia |
| Pennsylvania |
| United States |