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

Primary Purpose

Non Small Cell Lung Cancer, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZD4054
Pemetrexed
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, Phase II, ZD4054, Pemetrexed, Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

ZD4054 + Pemetrexed

ZD4054 matched placebo + pemetrexed

Outcomes

Primary Outcome Measures

Time to Death
Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)

Secondary Outcome Measures

Progression-free Survival
Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method

Full Information

First Posted
September 2, 2008
Last Updated
April 26, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00745875
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Lung Cancer
Keywords
NSCLC, Phase II, ZD4054, Pemetrexed, Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ZD4054 + Pemetrexed
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
ZD4054 matched placebo + pemetrexed
Intervention Type
Drug
Intervention Name(s)
ZD4054
Other Intervention Name(s)
Zibotentan
Intervention Description
10mg oral tablet, once daily
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
500mg2/m IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10mg oral tablet, once daily
Primary Outcome Measure Information:
Title
Time to Death
Description
Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)
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).
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method
Time Frame
Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Morris, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christos Chouaid, MD, Prof
Organizational Affiliation
Hospital Saint-Antoine, Cedex, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Jicin
Country
Czech Republic
Facility Name
Research Site
City
Prague
Country
Czech Republic
Facility Name
Research Site
City
Cedex
Country
France
Facility Name
Research Site
City
Strasbourg
Country
France
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
Country
Romania
Facility Name
Research Site
City
Chernivtsi
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Sumy
Country
Ukraine
Facility Name
Research Site
City
Uzngorod
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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