Trial Information
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
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
Type of Study:
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
Outcome Measure:
Time to Death
Outcome Description:
Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)
Outcome 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).
Safety Issue:
No
Principal Investigator
Thomas Morris, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Bulgaria: Bulgarian Drug Agency
Study ID:
D4320C00035
NCT ID:
NCT00745875
Start Date:
August 2008
Completion Date:
January 2010
Related Keywords:
- Non Small Cell Lung Cancer
- Lung Cancer
- NSCLC
- Phase II
- ZD4054
- Pemetrexed
- Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms