NCT00745875

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
5 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

June 6, 2012

Completed
Last Updated

June 6, 2012

Status Verified

April 1, 2012

Enrollment Period

1.4 years

First QC Date

September 2, 2008

Results QC Date

April 26, 2012

Last Update Submit

April 26, 2012

Conditions

Non Small Cell Lung CancerLung Cancer

Keywords

NSCLCPhase IIZD4054PemetrexedLung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

ZD4054 + Pemetrexed

Drug: ZD4054Drug: Pemetrexed

2

PLACEBO COMPARATOR

ZD4054 matched placebo + pemetrexed

Drug: PemetrexedDrug: Placebo

Interventions

ZD4054DRUG

10mg oral tablet, once daily

Also known as: Zibotentan
1
PemetrexedDRUG

500mg2/m IV infusion

Also known as: Alimta
12
PlaceboDRUG

10mg oral tablet, once daily

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

research Site

Pleven, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Varna, Bulgaria

Location

Research Site

Jičín, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Cedex, France

Location

Research Site

Strasbourg, France

Location

Research Site

Bucharest, Romania

Location

Research Site

Cluj-Napoca, Romania

Location

Research Site

Chernivtsi, Ukraine

Location

Research Site

Kiev, Ukraine

Location

Research Site

Sumy, Ukraine

Location

Research Site

Uzngorod, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

ZD4054Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Thomas Morris, MD

    AstraZeneca

    STUDY DIRECTOR

  • Christos Chouaid, MD, Prof

    Hospital Saint-Antoine, Cedex, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 6, 2012

Results First Posted

June 6, 2012

Record last verified: 2012-04

Locations

RO(2)CZ(2)FR(2)BU(3)UA(4)