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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (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. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB028060 | Experimental | Subjects will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group of patients may be enrolled and receive study drug. The initial cohort will be treated with 10 mg QD. The second cohort will be treated with 20 mg QD. The third cohort will be treated with 50 mg QD. Subsequent cohorts will be treated with two times the dose of the prior cohort to a limited toxicity level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB028060 | Drug | 10 mg and 50 mg capsules will be provided and dosed per the dosing schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be the primary endpoint and will be assessed by monitoring the frequency, duration, and severity of AEs | Baseline and every 1-2 weeks based on protocol visit schedule until the end of study or early termination visit. |
| Measure | Description | Time Frame |
|---|---|---|
| c-MET inhibitory activity determined by the relationship between blood levels of INCB028060 and the percent inhibition of c-MET phosphorylation | Samples will be collected at 0 (predose) and 2, 4, and 6 hours after dosing on Day 1 and Day 15 of Cycle 1 for subjects undergoing full PK analysis. | Predose, specific hours post-dose on day and Day 15 of Cycle 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lance Leopold | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore | Maryland | United States | ||||
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000613976 | capmatinib |
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| Nashville |
| Tennessee |
| United States |