ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study
NCT ID: NCT00745875
Last Updated: 2012-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2008-08-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
ZD4054 + Pemetrexed
ZD4054
10mg oral tablet, once daily
Pemetrexed
500mg2/m IV infusion
2
ZD4054 matched placebo + pemetrexed
Pemetrexed
500mg2/m IV infusion
Placebo
10mg oral tablet, once daily
Interventions
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ZD4054
10mg oral tablet, once daily
Pemetrexed
500mg2/m IV infusion
Placebo
10mg oral tablet, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients that meet one of the following criteria: - progressed following one prior platinum-based chemotherapy regimen for locally advanced or metastatic disease; -progressed within 6 months of adjuvant platinum-based chemotherapy
* Life expectancy of \> 12 weeks
Exclusion Criteria
* Prior therapy with an ET receptor antagonist
* Any recent surgery, unhealed surgical incision, severe concomitant medical condition (eg, unstable cardiac, hepatic or renal disease) or significant laboratory finding which makes it undesirable for the patient to participate
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Morris, MD
Role: STUDY_DIRECTOR
AstraZeneca
Christos Chouaid, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Hospital Saint-Antoine, Cedex, France
Locations
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research Site
Pleven, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Jičín, , Czechia
Research Site
Prague, , Czechia
Research Site
Cedex, , France
Research Site
Strasbourg, , France
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Chernivtsi, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Sumy, , Ukraine
Research Site
Uzngorod, , Ukraine
Countries
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Other Identifiers
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D4320C00035
Identifier Type: -
Identifier Source: org_study_id
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