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ZD4054 Phase II Non-Small Cell Lung Cancer Study

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Active 18 and over Pharmaceutical / Industry D4320C00035
NCT00745875

Trial Description

Summary

The aim of this study is to collect initial efficacy and safety data on the use of a new treatment ZD4054 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

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

AstraZeneca Pharmaceuticals LP

Thomas Morris, MD

Study Director

Christos Chouaid, MD, Prof

Principal Investigator

AstraZeneca Clinical Study Information

Ph: 800-236-9933

Trial Sites

Czech Republic

Prague

Research Site

France

Cedex

Research Site

Republic of Bulgaria

Pleven

research Site

Sofia

Research Site

Romania

Bucharest

Research Site

Cluj-Napoca

Research Site

Ukraine

Chernivtsi

Research Site

Kiev

Research Site

Sumy

Research Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00745875
Information obtained from ClinicalTrials.gov on April 09, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.