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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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)
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Secondary ID [1]
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EUDRACT Number 2006-002384-12
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Secondary ID [2]
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D4200C00044
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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0
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Kidney
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Cancer
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0
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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).
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Timepoint [1]
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Time to death in months
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Secondary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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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
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Timepoint [1]
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RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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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.
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Timepoint [2]
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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.
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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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
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Timepoint [3]
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RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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Secondary outcome [4]
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Duration of Response (DoR)
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Assessment method [4]
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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)
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Timepoint [4]
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RECIST tumour assessments carried out every 8 weeks from randomisation until objective disease progression
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Secondary outcome [5]
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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)
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Assessment method [5]
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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.
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Timepoint [5]
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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
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2014
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Sample size
Target
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Accrual to date
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Final
1140
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Recruitment in Australia
Recruitment state(s)
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Research Site - Fitzroy
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Research Site - Woodville South
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- Fitzroy
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- Perth
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- St. Leonards
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- Tugan
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- Woodville South
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genzyme, a Sanofi Company
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00404924
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Trial related presentations / publications
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Address
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00404924
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