Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244 (Selumetinib) When Given as a Monotherapy in Japanese Patients With Advanced Solid Malignancies, and When Given in Combination With Docetaxel as 2nd Line Therapy in Japanese Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
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.
The objective of the combination therapy part of this study will be to investigate the
safety and tolerability of AZD6244 given in combination with docetaxel as 2nd line therapy
in Japanese patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage
IIIB-IV). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be
investigated.
The objective of the monotherapy part of this study will be to investigate the safety and
tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid
malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be
investigated.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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