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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non Small Cell Lung Cancer, Lung Cancer

Thank you

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

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