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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00404924




Registration number
NCT00404924
Ethics application status
Date submitted
28/11/2006
Date registered
29/11/2006
Date last updated
30/09/2016

Titles & IDs
Public title
ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures
Scientific title
A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)
Secondary ID [1] 0 0
EUDRACT Number 2006-002384-12
Secondary ID [2] 0 0
D4200C00044
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZD6474 (vandetanib)
Other interventions - Best Supportive Care

Placebo comparator: 1 - Best Supportive Care

Experimental: 2 - Vandetanib + Best Supportive Care


Treatment: Drugs: ZD6474 (vandetanib)
once daily oral tablet

Other interventions: Best Supportive Care
standard of care
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Time to death in months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
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

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
1140
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Fitzroy
Recruitment hospital [2] 0 0
Research Site - Perth
Recruitment hospital [3] 0 0
Research Site - St. Leonards
Recruitment hospital [4] 0 0
Research Site - Tugan
Recruitment hospital [5] 0 0
Research Site - Woodville South
Recruitment postcode(s) [1] 0 0
- Fitzroy
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- St. Leonards
Recruitment postcode(s) [4] 0 0
- Tugan
Recruitment postcode(s) [5] 0 0
- Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
Argentina
State/province [3] 0 0
Bahia Blanca
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad de Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
La Plata
Country [6] 0 0
Argentina
State/province [6] 0 0
Rosario
Country [7] 0 0
Argentina
State/province [7] 0 0
San Miguel de Tucuman
Country [8] 0 0
Argentina
State/province [8] 0 0
Santa Fe
Country [9] 0 0
Austria
State/province [9] 0 0
Linz
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Antwerpen
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Belgium
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Brussels (Woluwé-St-Lambert)
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Belgium
State/province [14] 0 0
Charleroi
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liège
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Canada
State/province [19] 0 0
Alberta
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Chengdu
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China
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Dalian
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China
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Guangzhou
Country [26] 0 0
China
State/province [26] 0 0
Nanjing
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China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Wuhan
Country [29] 0 0
China
State/province [29] 0 0
Xi'an
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France
State/province [30] 0 0
Brest Cedex
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France
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Caen Cedex
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France
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Lyon Cedex
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France
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Marseille Cedex 9
Country [34] 0 0
France
State/province [34] 0 0
Nice Cedex
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France
State/province [35] 0 0
Pierre Benite Cedex
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France
State/province [36] 0 0
Toulon Armees
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Germany
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Bad Berka
Country [38] 0 0
Germany
State/province [38] 0 0
Donaustauf
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Germany
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Frankfurt
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Germany
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Gauting
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Germany
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Göttingen
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Germany
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Halle
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Germany
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Hannover
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Germany
State/province [44] 0 0
Karlsruhe
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Germany
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Leipzig
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Germany
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Löwenstein
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Germany
State/province [47] 0 0
Mannheim
Country [48] 0 0
Germany
State/province [48] 0 0
München
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Hong Kong
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Hong Kong
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Tel-Hashomer
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Israel
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Zerifin
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Italy
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Ancona
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Italy
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Bologna
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Italy
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Catania
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Italy
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Genova
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Italy
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Milano
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Italy
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Orbassano
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Italy
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Parma
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Italy
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Roma
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Italy
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Rozzano
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Italy
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S.Andrea delle Fratte
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Italy
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Sondalo
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Italy
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Udine
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Mexico
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México
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Mexico
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Zapopan
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Netherlands
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St Maartenskliniek
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Peru
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Lima
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Philippines
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Cebu City
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Philippines
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Manila
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Philippines
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Quezon City
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Singapore
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Singapore
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Spain
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Baracaldo(Vizcaya)
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Spain
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Barcelona
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Spain
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Santander
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Spain
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Valencia
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Taiwan
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Changhua
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Taiwan
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Kao Hsiung
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Taiwan
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Kaohsiung Hsien
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Taiwan
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Kaohsiung
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Taiwan
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Liou Ying Township
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Tao-Yuan
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Thailand
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Bangkok
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Thailand
State/province [91] 0 0
Chiang Mai
Country [92] 0 0
Thailand
State/province [92] 0 0
Khon Kaen
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Birmingham
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United Kingdom
State/province [94] 0 0
Chelmsford
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United Kingdom
State/province [95] 0 0
Dundee
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Maidstone
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00404924