Clinical Trial: Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase I Dose Escalation Study of NMS-1286937 Administered to Adult Patients With Advanced/Metastatic Solid Tumors
Brief Summary: 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.
Detailed Summary:
Sponsor: Nerviano Medical Sciences
Current Primary Outcome: Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs) [ Time Frame: Cycle 1 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Nerviano Medical Sciences
Dates:
Date Received: November 16, 2009
Date Started: November 2009
Date Completion:
Last Updated: September 6, 2012
Last Verified: September 2012
