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

Arm | Intervention/treatment |
---|---|
Experimental: 1
ZD4054 + Pemetrexed
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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 |
- 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)
- 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

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

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
Bulgaria | |
research Site | |
Pleven, Bulgaria | |
Research Site | |
Sofia, Bulgaria | |
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Varna, Bulgaria | |
Czech Republic | |
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Jicin, Czech Republic | |
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Prague, Czech Republic | |
France | |
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Cedex, France | |
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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 |
Study Director: | Thomas Morris, MD | AstraZeneca | |
Principal Investigator: | Christos Chouaid, MD, Prof | Hospital Saint-Antoine, Cedex, France |
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 |
NSCLC Phase II ZD4054 Pemetrexed Lung Cancer |
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 |