Spots Global Cancer Trial Database for Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors

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Trial Identification

Brief Title: Clinical Study of Oral IGF-1R Inhibitor in Subjects With Advanced Refractory Solid Tumors

Official Title: An Open Label Multicentre Phase 1 Study of Oral IGF-1R Inhibitor PL225B in Subjects With Advanced Refractory Solid Tumors.

Study ID: NCT01779336

Conditions

Advanced Refractory Solid Tumors

Interventions

PL225B

Study Description

Brief Summary: Clinical study of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity (ies) of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid tumors.

Detailed Description: An open label multicentre Phase 1 study of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid tumors. This is a dose-finding trial using the modified Accelerated Titration Design with 3 new subjects per cohort and 100% dose increments in the accelerated phase followed by standard phase with 40% dose increments.Subjects will receive study drug on a daily basis for twenty-one (21) days according to the dose and schedule specified for a particular cohort of therapy. Toxicity profile of the drug will be assessed during Cycle 1 of subject treatment in each cohort for determination of Maximum Tolerated Dose (MTD) according to the schedule given below.