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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00410761




Registration number
NCT00410761
Ethics application status
Date submitted
6/12/2006
Date registered
13/12/2006
Date last updated
9/12/2019

Titles & IDs
Public title
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
Scientific title
An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer
Secondary ID [1] 0 0
2005-005077-29
Secondary ID [2] 0 0
D4200C00058
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Thyroid
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZD6474 (Vandetanib)

No Intervention: 1 - Placebo vandetanib

Experimental: 2 - Vandetanib


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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival(PFS) - Median time to progression (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. Values here are estimated (from a Weibull model) as the medians were not met.
Timepoint [1] 0 0
RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.
Secondary outcome [1] 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)>= 12 weeks, progressive disease (PD) or NE.
Timepoint [1] 0 0
RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed =4 weeks following the date of first response.
Secondary outcome [2] 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) >= 12 weeks
Timepoint [2] 0 0
RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent
Secondary outcome [3] 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). Values are estimated as the medians weren't met
Timepoint [3] 0 0
RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent
Secondary outcome [4] 0 0
Overall Survival (OS) - As data was immature at data cut off, number of death events is quoted
Timepoint [4] 0 0
Number of deaths since randomisation
Secondary outcome [5] 0 0
Biochemical Response Calcitonin (CTN) - Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.
Timepoint [5] 0 0
Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up
Secondary outcome [6] 0 0
Biochemical Response Carcinoembryonic Antigen (CEA) - Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.
Timepoint [6] 0 0
Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up
Secondary outcome [7] 0 0
Time to Worsening of Pain (TWP) - TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.
Timepoint [7] 0 0
During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.

Eligibility
Key inclusion criteria
- Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or
sporadic Medullary Thyroid Cancer.

- Presence of measurable tumor

- Able to swallow medication
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Major surgery within 4 weeks before randomization

- Last dose of prior chemotherapy received less than 4 weeks prior to randomization

- Radiation therapy within the last 4 weeks prior to randomization(with exception of
palliative radiotherapy)

- Brain metastases or spinal cord compression, unless treated at least 4 weeks before
first dose and stable without steroid treatment for 10 days

- Significant cardiac events

- Previous ZD6474 treatment

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
Active, not recruiting
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
Investigational Site Number 1001 - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
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United States of America
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Illinois
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Kentucky
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Ohio
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Oregon
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South Carolina
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Texas
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Vermont
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Austria
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Wien
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Bruxelles
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Belgium
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Leuven
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Brazil
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Porto Alegre
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Brazil
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Ribeirão Preto
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Canada
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Calgary
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London
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Moncton
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Sherbrooke
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Toronto
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Czechia
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Praha 5
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Odense C
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France
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BORDEAUX Cedex
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France
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LYON Cedex 8
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France
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Villejuif
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Germany
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Essen
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Germany
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Halle
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Germany
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Würzburg
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Hungary
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Pécs
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India
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Mumbai
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India
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Vellore
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Catania
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Milano
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Napoli
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Pisa
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Roma
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Italy
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Siena
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Korea, Republic of
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Seoul
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Mexico
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Cd. Madero
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Mexico
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Mexico City
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Mexico
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México
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Groningen
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Utrecht
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Gliwice
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Poznan
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Coimbra
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Lisboa
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Romania
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Bucarest
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Russian Federation
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Obninsk
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Serbia
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Belgrade
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Serbia
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Belgrad
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Spain
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Madrid
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Spain
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Pamplona
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Sweden
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Stockholm
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Uppsala
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Switzerland
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Basel
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Switzerland
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Bern

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer
patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body,
about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.
Trial website
https://clinicaltrials.gov/show/NCT00410761
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