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ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00745875
First received: September 2, 2008
Last updated: April 26, 2012
Last verified: April 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Non Small Cell Lung Cancer Lung Cancer | Drug: ZD4054 Drug: Pemetrexed Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Time to Death [ 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). ]Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)
Secondary Outcome Measures:
- Progression-free Survival [ Time Frame: 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
| Enrollment: | 66 |
| Study Start Date: | August 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ZD4054 + Pemetrexed
|
Drug: ZD4054
10mg oral tablet, once daily
Other Name: Zibotentan
Drug: Pemetrexed
500mg2/m IV infusion
Other Name: Alimta
|
|
Placebo Comparator: 2
ZD4054 matched placebo + pemetrexed
|
Drug: Pemetrexed
500mg2/m IV infusion
Other Name: Alimta
Drug: Placebo
10mg oral tablet, once daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745875
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745875
Locations
| Bulgaria | |
| research Site | |
| Pleven, Bulgaria | |
| Research Site | |
| Sofia, Bulgaria | |
| Research Site | |
| Varna, Bulgaria | |
| Czech Republic | |
| Research Site | |
| Jicin, Czech Republic | |
| Research Site | |
| Prague, Czech Republic | |
| France | |
| Research Site | |
| Cedex, France | |
| Research Site | |
| Strasbourg, France | |
| Romania | |
| Research Site | |
| Bucharest, Romania | |
| Research Site | |
| Cluj-Napoca, Romania | |
| Ukraine | |
| Research Site | |
| Chernivtsi, Ukraine | |
| Research Site | |
| Kiev, Ukraine | |
| Research Site | |
| Sumy, Ukraine | |
| Research Site | |
| Uzngorod, Ukraine | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Thomas Morris, MD | AstraZeneca |
| Principal Investigator: | Christos Chouaid, MD, Prof | Hospital Saint-Antoine, Cedex, France |
More Information
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00745875 History of Changes |
| Other Study ID Numbers: |
D4320C00035 |
| Study First Received: | September 2, 2008 |
| Results First Received: | April 26, 2012 |
| Last Updated: | April 26, 2012 |
Keywords provided by AstraZeneca:
|
NSCLC Phase II ZD4054 Pemetrexed Lung Cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 21, 2017