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

Purpose

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	Intervention	Phase
Non Small Cell Lung Cancer Lung Cancer	Drug: ZD4054 Drug: Pemetrexed Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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). ] [ Designated as safety issue: No ]
Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method


Enrollment:	66
Study Start Date:	August 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745875

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

No publications provided


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00745875 History of Changes
Other Study ID Numbers:	D4320C00035
Study First Received:	September 2, 2008
Results First Received:	April 26, 2012
Last Updated:	April 26, 2012
Health Authority:	Bulgaria: Bulgarian Drug Agency Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Romania: National Medicines Agency Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:


NSCLC Phase II ZD4054 Pemetrexed Lung Cancer

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms	Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015