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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745875
• Other study ID #: D4320C00035
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2008
• Last updated: April 26, 2012
• Start date: August 2008
• Est. completion date: January 2010

Study information

• Verified date: April 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Romania: National Medicines AgencyUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• ZD4054
10mg oral tablet, once daily
• Pemetrexed
500mg2/m IV infusion
• Placebo
10mg oral tablet, once daily

Locations

Country	Name	City	State
Bulgaria	research Site	Pleven
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Czech Republic	Research Site	Jicin
Czech Republic	Research Site	Prague
France	Research Site	Cedex
France	Research Site	Strasbourg
Romania	Research Site	Bucharest
Romania	Research Site	Cluj-Napoca
Ukraine	Research Site	Chernivtsi
Ukraine	Research Site	Kiev
Ukraine	Research Site	Sumy
Ukraine	Research Site	Uzngorod

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  France,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Death	Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)	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).	No
Secondary	Progression-free Survival	Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method	Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation	No