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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - 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).
Timepoint [1] 0 0
Time to death in months
Secondary outcome [1] 0 0
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
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) - 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.
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) - 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
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) - 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)
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) - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Arizona
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United States of America
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Tennessee
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Argentina
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Bahia Blanca
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Argentina
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Ciudad de Buenos Aires
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Argentina
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Santa Fe
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Austria
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Linz
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Austria
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Salzburg
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Vienna
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Antwerpen
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Belgium
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Brussels (Woluwé-St-Lambert)
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Leuven
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Liège
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Alberta
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Ontario
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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
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China
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Nanjing
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China
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Shanghai
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China
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Wuhan
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China
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Xi'an
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France
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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
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France
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Nice Cedex
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France
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Pierre Benite Cedex
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France
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Toulon Armees
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Germany
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Bad Berka
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Donaustauf
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Frankfurt
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Gauting
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Halle
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Hannover
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Karlsruhe
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Leipzig
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Löwenstein
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Mannheim
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München
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Hong Kong
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Jerusalem
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Kfar Saba
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Tel-Hashomer
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Zerifin
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Ancona
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Bologna
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Catania
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Roma
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Rozzano
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S.Andrea delle Fratte
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Sondalo
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Udine
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Korea, Republic of
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Goyang-si
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Seongnam
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Korea, Republic of
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Seoul
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Suwon
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Zapopan
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Netherlands
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Lima
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Santander
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Valencia
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Changhua
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Kao Hsiung
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Kaohsiung Hsien
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Kaohsiung
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Liou Ying Township
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Taichung
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Taipei
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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United Kingdom
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Birmingham
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Chelmsford
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United Kingdom
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Dundee
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Maidstone
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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
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.
Trial website
https://clinicaltrials.gov/show/NCT00404924
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

Summary results
Other publications