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The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMS-1286937 | Drug | Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs) | Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL), volume of distribution, half-life (t½) | Cycles 1 and 2 | |
| Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariangela Mariani, Biol Sci D | Nerviano Medical Sciences | Study Director |
| Maria Adele Pacciarini, Biol Sci D | Nerviano Medical Sciences | Study Director |
| Glen J Weiss, MD | Arizona TGen Clinical Reserch Services at Scottsdale Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona TGen Clinical Research Services at Scottsdale Heathcare | Scottsdale | Arizona | 85258 | United States |
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| Cycles 1 and 2 |