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Discontinuation of clinical investigation with NMS-1116354
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The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMS-1116354 | Drug | Oral daily administration for 7 consecutive days every 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose (MTD) | 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), time of occurence of Cmax (tmax) and half-life (t½) | Cycles 1 and 2 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyriakos Papadopoulos, MD, MSc | South Texas Accelerated Research Therapeutics (START) | Principal Investigator |
| Bernard Laffranchi, MD | Nerviano Medical Sciences | Study Director |
| Stefania Crippa, Biotech D, PhD | Nerviano Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas | 78229 | United States |
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