Study identifier:D4320C00035
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase II, Double-blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of ZD4054 (Zibotentan) in Combination with Pemetrexed (Alimta®) vs. Pemetrexed Alone in Patients with Non-small Cell Lung Cancer who Have Failed One Prior Platinum-based Chemotherapy Regimen
Non Small Cell Lung Cancer
Phase 2
No
ZD4054, Pemetrexed, Placebo
All
66
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 (Zibotentan) when used in combination with pemetrexed (a standard chemotherapy agent) for the treatment of non-small cell lung cancer compared to treatment with pemetrexed alone
Location
Location
Varna, Bulgaria
Location
Pleven, Bulgaria
Location
Sofia, Bulgaria
Location
Prague, Czech Republic
Location
Jicin, Czech Republic
Location
Cedex, France
Location
Strasbourg, France
Location
Bucharest, Romania
Arms | Assigned Interventions |
---|---|
Experimental: 1 ZD4054 + Pemetrexed | Drug: ZD4054 10mg oral tablet, once daily Other Name: Zibotentan Drug: Pemetrexed 500mg2/m IV infusion Other Name: Alimta |
Placebo Comparator: 2 ZD4054 matched placebo + pemetrexed | Drug: Pemetrexed 500mg2/m IV infusion Other Name: Alimta Drug: Placebo 10mg oral tablet, once daily |
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