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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00410761
Ethics application status
Date submitted
6/12/2006
Date registered
13/12/2006
Date last updated
2/10/2023

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)
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then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.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)
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)
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then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent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)
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)
Timepoint [4] 0 0
Number of deaths since randomisation
Secondary outcome [5] 0 0
Biochemical Response Calcitonin (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)
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)
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
Sex
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
30/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
Accrual to date
Final
437
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Vermont
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Belgium
State/province [18] 0 0
Bruxelles
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Brazil
State/province [20] 0 0
Porto Alegre
Country [21] 0 0
Brazil
State/province [21] 0 0
Ribeirão Preto
Country [22] 0 0
Canada
State/province [22] 0 0
Calgary
Country [23] 0 0
Canada
State/province [23] 0 0
London
Country [24] 0 0
Canada
State/province [24] 0 0
Moncton
Country [25] 0 0
Canada
State/province [25] 0 0
Sherbrooke
Country [26] 0 0
Canada
State/province [26] 0 0
Toronto
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 5
Country [28] 0 0
Denmark
State/province [28] 0 0
Odense C
Country [29] 0 0
France
State/province [29] 0 0
BORDEAUX Cedex
Country [30] 0 0
France
State/province [30] 0 0
LYON Cedex 8
Country [31] 0 0
France
State/province [31] 0 0
Villejuif
Country [32] 0 0
Germany
State/province [32] 0 0
Essen
Country [33] 0 0
Germany
State/province [33] 0 0
Halle
Country [34] 0 0
Germany
State/province [34] 0 0
Würzburg
Country [35] 0 0
Hungary
State/province [35] 0 0
Pécs
Country [36] 0 0
India
State/province [36] 0 0
Mumbai
Country [37] 0 0
India
State/province [37] 0 0
Vellore
Country [38] 0 0
Italy
State/province [38] 0 0
Catania
Country [39] 0 0
Italy
State/province [39] 0 0
Milano
Country [40] 0 0
Italy
State/province [40] 0 0
Napoli
Country [41] 0 0
Italy
State/province [41] 0 0
Pisa
Country [42] 0 0
Italy
State/province [42] 0 0
Roma
Country [43] 0 0
Italy
State/province [43] 0 0
Siena
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul
Country [45] 0 0
Mexico
State/province [45] 0 0
Cd. Madero
Country [46] 0 0
Mexico
State/province [46] 0 0
Mexico City
Country [47] 0 0
Mexico
State/province [47] 0 0
México
Country [48] 0 0
Netherlands
State/province [48] 0 0
Groningen
Country [49] 0 0
Netherlands
State/province [49] 0 0
Utrecht
Country [50] 0 0
Poland
State/province [50] 0 0
Gliwice
Country [51] 0 0
Poland
State/province [51] 0 0
Poznan
Country [52] 0 0
Poland
State/province [52] 0 0
Warszawa
Country [53] 0 0
Portugal
State/province [53] 0 0
Coimbra
Country [54] 0 0
Portugal
State/province [54] 0 0
Lisboa
Country [55] 0 0
Romania
State/province [55] 0 0
Bucarest
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Obninsk
Country [57] 0 0
Serbia
State/province [57] 0 0
Belgrade
Country [58] 0 0
Serbia
State/province [58] 0 0
Belgrad
Country [59] 0 0
Spain
State/province [59] 0 0
Madrid
Country [60] 0 0
Spain
State/province [60] 0 0
Pamplona
Country [61] 0 0
Sweden
State/province [61] 0 0
Stockholm
Country [62] 0 0
Sweden
State/province [62] 0 0
Uppsala
Country [63] 0 0
Switzerland
State/province [63] 0 0
Basel
Country [64] 0 0
Switzerland
State/province [64] 0 0
Bern

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/NCT00410761