Clinical trial NCT00745875: ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lung Cancer
Keywords: NSCLC
Phase II
ZD4054
Pemetrexed
Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


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

Primary outcomes:
measure: Time to Death
timeFrame: 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 outcomes:
measure: Progression-free Survival
timeFrame: Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Jicin
country: Czech Republic
facility: Research Site
city: Prague
country: Czech Republic
facility: Research Site
city: Cedex
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Sumy
country: Ukraine
facility: Research Site
city: Uzngorod
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Thomas Morris, MD
role: STUDY_DIRECTOR
affiliation: Hospital Saint-Antoine, Cedex, France
name: Christos Chouaid, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: