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ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study

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ClinicalTrials.gov Identifier: NCT00745875
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : June 6, 2012
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Lung Cancer Drug: ZD4054 Drug: Pemetrexed Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to Death [ Time Frame: Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010). ]
    Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)


Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation ]
    Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC on entry into study suitable for pemetrexed therapy
  • 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 treatment with pemetrexed in the last 12 months.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745875


Locations
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Bulgaria
research Site
Pleven, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Czech Republic
Research Site
Jicin, Czech Republic
Research Site
Prague, Czech Republic
France
Research Site
Cedex, France
Research Site
Strasbourg, France
Romania
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, Romania
Ukraine
Research Site
Chernivtsi, Ukraine
Research Site
Kiev, Ukraine
Research Site
Sumy, Ukraine
Research Site
Uzngorod, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Thomas Morris, MD AstraZeneca
Principal Investigator: Christos Chouaid, MD, Prof Hospital Saint-Antoine, Cedex, France
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00745875    
Other Study ID Numbers: D4320C00035
First Posted: September 3, 2008    Key Record Dates
Results First Posted: June 6, 2012
Last Update Posted: June 6, 2012
Last Verified: April 2012
Keywords provided by AstraZeneca:
NSCLC
Phase II
ZD4054
Pemetrexed
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors