AT13148 - Otsuka
Phase I study of AT13148, a novel AGC kinase inhibitor (clinicaltrials.gov) - Apr 25, 2012 - P1, N=40; Not yet recruiting; New P1 trial 
New trial • Oncology
http://clinicaltrials.gov/show/NCT01585701
 
Apr 25, 2012
 
This study is not yet open for participant recruitment. Verified April 2012 by Cancer Research UK First Received on April 25, 2012. No Changes Posted Sponsor: Cancer Research UK Information provided by (Responsible Party): Cancer Research UK ClinicalTrials.gov Identifier: NCT01585701 Purpose The purpose of this first clinical study of the noval multiple AGC kinase inhibitor, AT13148, is to identify the recommended dose for future studies in cancer patients by exploring the safety and maximum tolerated dose and biological effects in patients with advanced solid tumours. Condition  Advanced Solid Tumours Intervention Biological: AT13148 Phase Phase 1 Study Type: Interventional Study Design: Masking: Open Label Primary Purpose: Treatment Official Title: A Cancer Research UK Phase I First in Man Study of the Novel AGC Kinase Inhibitor AT13148 Given Orally in Patients With Advanced Solid Tumours. Resource links provided by NLM: MedlinePlus related topics: Cancer U.S. FDA Resources Further study details as provided by Cancer Research UK: Primary Outcome Measures: Determining a dose at which no more than one patient out of up to six patients at the same dose level experience a highly probably or probably drug-related doselimiting toxicity (DLT). [ Designated as safety issue: Yes ] Determining causality of each adverse event Adverse Event to AT13148 and grading severity according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02. [ Designated as safety issue: Yes ] Secondary Outcome Measures: Determining the correlation between pharmacokinetic studies and toxicity and/or efficacy. [ Designated as safety issue: No ] Any response (stable disease, partial response or complete response) in any of the patients as determined by the Response Evaluation Criteria in Solid Tumours RECIST) criteria version 1.1.criteria version 1.1. [ Designated as safety issue: No ] Estimated Enrollment: 40 Study Start Date: April 2012 Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)