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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Study Director:	Thomas Morris, MD	AstraZeneca
Principal Investigator:	Christos Chouaid, MD, Prof	Hospital Saint-Antoine, Cedex, France

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00745875 History of Changes
Other Study ID Numbers:	D4320C00035
First Posted:	September 3, 2008
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:

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