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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.
Arizona TGen Clinical Research Services at Scottsdale Heathcare
Scottsdale, Arizona, United States
Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)
Time frame: Cycle 1
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)
Time frame: Cycles 1 and 2
Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients
Time frame: Cycles 1 and 2
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