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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00404924
Other study ID # D4200C00044
Secondary ID EUDRACT Number 2
Status Completed
Phase Phase 3
First received November 28, 2006
Last updated February 9, 2015
Start date November 2006
Est. completion date November 2014

Study information

Verified date February 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.


Recruitment information / eligibility

Status Completed
Enrollment 1140
Est. completion date November 2014
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with Non-small cell lung cancer for which the standard cancer treatments of surgery, chemotherapy, radiation or other anticancer drugs are no longer appropriate treatments for you.

Exclusion Criteria:

- Patients who have had standard cancer treatments of surgery, chemotherapy or other systemic anti-cancer therapy within 4 weeks before start of study therapy.

- Three or more prior chemotherapy regimens.

- Significant cardiovascular events.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
ZD6474 (vandetanib)
once daily oral tablet
Other:
Best Supportive Care
standard of care

Locations

Country Name City State
Argentina Research Site Bahia Blanca
Argentina Research Site Ciudad de Buenos Aires
Argentina Research Site La Plata
Argentina Research Site Rosario
Argentina Research Site San Miguel de Tucuman
Argentina Research Site Santa Fe
Australia Research Site Fitzroy
Australia Research Site Perth
Australia Research Site St. Leonards
Australia Research Site Tugan
Australia Research Site Woodville South
Austria Research Site Linz
Austria Research Site Salzburg
Austria Research Site Vienna
Belgium Research Site Antwerpen
Belgium Research Site Brussels (Woluwé-St-Lambert)
Belgium Research Site Charleroi
Belgium Research Site Edegem
Belgium Research Site Gent
Belgium Research Site Leuven
Belgium Research Site Liège
Canada Research Site Edmonton Alberta
Canada Research Site Montreal Quebec
Canada Research Site Oshawa Ontario
Canada Research Site Toronto Ontario
China Research Site Beijing
China Research Site Chengdu
China Research Site Dalian
China Research Site Guangzhou
China Research Site Nanjing
China Research Site Shanghai
China Research Site Wuhan
China Research Site Xi'an
France Research Site Brest Cedex
France Research Site Caen Cedex
France Research Site Lyon Cedex
France Research Site Marseille Cedex 9
France Research Site Nice Cedex
France Research Site Pierre Benite Cedex
France Research Site Toulon Armees
Germany Research Site Bad Berka
Germany Research Site Donaustauf
Germany Research Site Frankfurt
Germany Research Site Gauting
Germany Research Site Göttingen
Germany Research Site Halle
Germany Research Site Hannover
Germany Research Site Karlsruhe
Germany Research Site Leipzig
Germany Research Site Löwenstein
Germany Research Site Mannheim
Germany Research Site München
Hong Kong Research Site Hong Kong
Israel Research Site Jerusalem
Israel Research Site Kfar Saba
Israel Research Site Tel-Hashomer
Israel Research Site Zerifin
Italy Research Site Ancona
Italy Research Site Bologna
Italy Research Site Catania
Italy Research Site Genova
Italy Research Site Milano
Italy Research Site Orbassano
Italy Research Site Parma
Italy Research Site Roma
Italy Research Site Rozzano
Italy Research Site S.Andrea delle Fratte
Italy Research Site Sondalo
Italy Research Site Udine
Korea, Republic of Research Site Goyang-si
Korea, Republic of Research Site Seongnam
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Suwon
Mexico Research Site México
Mexico Research Site Zapopan
Netherlands Research Site St Maartenskliniek
Peru Research Site Lima
Philippines Research Site Cebu City
Philippines Research Site Manila
Philippines Research Site Quezon City
Singapore Research Site Singapore
Spain Research Site Baracaldo(Vizcaya)
Spain Research Site Barcelona
Spain Research Site Santander
Spain Research Site Valencia
Taiwan Research Site Changhua
Taiwan Research Site Kao Hsiung
Taiwan Research Site Kaohsiung
Taiwan Research Site Kaohsiung Hsien
Taiwan Research Site Liou Ying Township
Taiwan Research Site Taichung
Taiwan Research Site Taipei
Taiwan Research Site Tao-Yuan
Thailand Research Site Bangkok
Thailand Research Site Chiang Mai
Thailand Research Site Khon Kaen
United Kingdom Research Site Birmingham
United Kingdom Research Site Chelmsford
United Kingdom Research Site Dundee
United Kingdom Research Site Maidstone
United Kingdom Research Site Manchester
United States Research Site Germantown Tennessee
United States Research Site Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  China,  France,  Germany,  Hong Kong,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Peru,  Philippines,  Singapore,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown). Time to death in months No
Secondary Progression-Free Survival (PFS) Median time (in months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression No
Secondary Objective Response Rate (ORR) The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria.
The categories for best objective response are CR, PR, stable disease (SD)>= 8 weeks, progressive disease (PD) or NE.
Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression. No
Secondary Disease Control Rate (DCR) Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression No
Secondary Duration of Response (DoR) Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment) RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression No
Secondary Time to Deterioration of Disease-related Symptoms (TDS) by Questionnaire - the Lung Cancer Subscale (LCS) a Selection of the FACT-L Focusing on Symptoms of Lung Cancer Plus Pain and Fatigue (LCS-PF) Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. Where assessment is by a selection of questions from the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire. Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication) and every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit No
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