drugset / Trial / NCT01545947

Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer

NCT01545947

Phase 1 Completed 76 enrolled Celgene Corporation
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this first study combining an investigational dual mTOR inhibitor, CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to establish a maximum tolerated dose level for each combination in order to evaluate their effects in future clinical trials for advanced non-small cell lung cancer.

Timeline

Start
2012-05-01
Primary completion
2014-12-11
Completion
2014-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 200 mg Oral
Subject Azacitidine Other / unclassified 300 mg Oral
Subject Erlotinib Small molecule 100 mg
Subject Erlotinib Small molecule 150 mg
Subject ONATASERTIB Small molecule 15 mg
Subject ONATASERTIB Small molecule 30 mg