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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Non Small Cell Lung Cancer, Lung Cancer

Intervention / Treatment
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* Drug: ZD4054
* Drug: Pemetrexed
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ZD4054 + Pemetrexed | Drug: ZD4054<br>* 10mg oral tablet, once daily<br>* Other names: Zibotentan;Drug: Pemetrexed<br>* 500mg2/m IV infusion<br>* Other names: Alimta;|
| Placebo Comparator: 2<br>ZD4054 matched placebo + pemetrexed | Drug: Pemetrexed<br>* 500mg2/m IV infusion<br>* Other names: Alimta;Drug: Placebo<br>* 10mg oral tablet, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death | Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability) | 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). | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Phase II, ZD4054, Pemetrexed, Lung Cancer