A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination With First Line Chemotherapy Regimens in Patients With Non-Small Cell Lung Cancer (NSCLC)
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability,
Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in
Combination with First Line Chemotherapy Regimens in Patients with Non-Small Cell Lung
Cancer (NSCLC)
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Investigate safety, tolerability and recommended Phase II dose of selumetinib in combination with first line chemotherapy by assessing adverse events.
Adverse events will be collected from consent until 28 days after the last dose of selumetinib, 180 days for the average patient
Yes
Ian Smith, MD
Study Director
AstraZeneca UK, MSD
United Kingdom: Medicines and Healthcare Products Regulatory Agency
D1532C00070
NCT01809210
April 2013
April 2014
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