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

NCT ID: NCT00745875

Last Updated: 2012-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-01-31

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

Detailed Description

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Conditions

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Non Small Cell Lung Cancer Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

ZD4054 + Pemetrexed

Group Type EXPERIMENTAL

ZD4054

Intervention Type DRUG

10mg oral tablet, once daily

Pemetrexed

Intervention Type DRUG

500mg2/m IV infusion

2

ZD4054 matched placebo + pemetrexed

Group Type PLACEBO_COMPARATOR

Pemetrexed

Intervention Type DRUG

500mg2/m IV infusion

Placebo

Intervention Type DRUG

10mg oral tablet, once daily

Interventions

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ZD4054

10mg oral tablet, once daily

Intervention Type DRUG

Pemetrexed

500mg2/m IV infusion

Intervention Type DRUG

Placebo

10mg oral tablet, once daily

Intervention Type DRUG

Other Intervention Names

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Zibotentan Alimta

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Research Site

Sofia, , Bulgaria

Site Status

Research Site

Varna, , Bulgaria

Site Status

Research Site

Jičín, , Czechia

Site Status

Research Site

Prague, , Czechia

Site Status

Research Site

Cedex, , France

Site Status

Research Site

Strasbourg, , France

Site Status

Research Site

Bucharest, , Romania

Site Status

Research Site

Cluj-Napoca, , Romania

Site Status

Research Site

Chernivtsi, , Ukraine

Site Status

Research Site

Kiev, , Ukraine

Site Status

Research Site

Sumy, , Ukraine

Site Status

Research Site

Uzngorod, , Ukraine

Site Status

Countries

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Bulgaria Czechia France Romania Ukraine

Other Identifiers

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D4320C00035

Identifier Type: -

Identifier Source: org_study_id

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