drugset / Trial / NCT01072266

A Dose-escalation Study in Subjects With Advanced Malignancies

NCT01072266

NaSingle-groupOpen-labelTreatment

Summary

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.

Timeline

Start
2010-01
Primary completion
2012-07
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capmatinib Small molecule 10 mg
Subject Capmatinib Small molecule 20 mg
Subject Capmatinib Small molecule 50 mg