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

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer; Lung Cancer
• Interventions: Drug: ZD4054; Drug: Pemetrexed; Drug: Placebo

• Registration Number: NCT00745875
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-04
• Results First Submitted: 2012-04-26
• Results First Submitted QC: 2012-04-26
• Last Update Submitted: 2012-04-26
• Results First Posted: 2012-06-06
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ZD4054	ZD4054 + Pemetrexed
2	Placebo	ZD4054 matched placebo + pemetrexed
2	Pemetrexed	ZD4054 matched placebo + pemetrexed
1	Pemetrexed	ZD4054 + Pemetrexed

Primary Outcome Measures

Name	Time	Method
Time to Death	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 Outcome Measures

Name	Time	Method
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	Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method

Trial Locations

Locations (2)

Research Site; 🇺🇦 Uzngorod, Ukraine

research Site; 🇧🇬 Pleven, Bulgaria