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
Overview
- Phase
- Phase 2
- Intervention
- ZD4054
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Time to Death
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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
Investigators
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
Arms & Interventions
1
ZD4054 + Pemetrexed
Intervention: ZD4054
1
ZD4054 + Pemetrexed
Intervention: Pemetrexed
2
ZD4054 matched placebo + pemetrexed
Intervention: Pemetrexed
2
ZD4054 matched placebo + pemetrexed
Intervention: Placebo
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Progression-free Survival(Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation)