drugset / Trial / NCT01605916

Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer

NCT01605916

Phase 1 Completed 33 enrolled AstraZeneca
NaSingle-groupOpen-labelTreatment

Summary

The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.

Timeline

Start
2012-06
Primary completion
2015-04
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Selumetinib Small molecule 25 mg Oral
Subject Selumetinib Small molecule 50 mg Oral
Subject Selumetinib Small molecule 75 mg Oral