Clinical Trial: Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors

Brief Summary: The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors.

Detailed Summary:
Sponsor: Nerviano Medical Sciences

Current Primary Outcome: First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD) [ Time Frame: 3 weeks ]

Original Primary Outcome: First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD) [ Time Frame: Cycle 1 ]

Current Secondary Outcome: 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) [ Time Frame: 6 weeks ]

Original Secondary Outcome: 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) [ Time Frame: Cycle 1 and 2 ]

Information By: Nerviano Medical Sciences

Dates:
Date Received: March 22, 2010
Date Started: January 2010
Date Completion:
Last Updated: September 6, 2012
Last Verified: September 2012