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A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT00358956
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : August 31, 2012
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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Brief Summary:
This will be a Phase II, open label study to establish the effect of once-daily oral doses of ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid cancer in whom no standard therapeutic option is available.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: ZD6474 (vandetanib) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label Study To Assess The Efficacy and Tolerability of ZD6474 (ZACTIMA™ ) 100 mg Monotherapy In Subjects With Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
Study Start Date : August 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: ZD6474 (vandetanib)
100 mg once daily oral tablet
Other Name: Caprelsa™


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. ]

    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.



Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. ]
    Median progression free survival (months) estimated from a Weibull model with corresponding 95% confidence intervals. Progression free survival is the time 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.

  2. Disease Control Rate (DCR) [ Time Frame: RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment. ]
    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) >= 24 weeks

  3. World Heath Organization (WHO) Performance Status [ Time Frame: WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment. ]
    Number of patients demonstrating an improvement from baseline to 24 weeks in WHO PS. Where WHO PS is the standard scale with patients scored (0 healthy - 5 dead) based on their physical capabilities

  4. Symptomatic Response [ Time Frame: Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment. ]
    Symptomatic response will be defined as at least a 50% decrease in the stool frequency (represented by a persistent decrease in stool frequency over 4 weeks), taking as reference the baseline (mean) level.

  5. Biochemical Response Calcitonin (CTN ) [ Time Frame: Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters) ]
    A patient's best biochemical response was calculated from assessments performed 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.

  6. Biochemical Response Carcinoembryonic Antigen CEA) [ Time Frame: Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation ]
    A patient's best biochemical response was calculated from assessments performed 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 Partial Response (PR) or Complete Response (CR) were first met.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Previously confirmed histological diagnosis of locally advanced or metastatic hereditary medullary thyroid carcinoma without standard therapeutic options
  • Aged 18 or over and a life expectancy of more than 12 weeks

Exclusion Criteria:

  • The last dose of prior chemo/radiation received less than 4 weeks before the start of study therapy
  • Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age, history of arrhythmia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358956


Locations
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United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Australia
Research Site
St Leonards, Australia
Canada, Quebec
Research Site
Sherbrooke, Quebec, Canada
Italy
Research Site
Pisa, Italy
Netherlands
Research Site
Utrecht, Netherlands
Romania
Research Site
Bucharest, Romania
Spain
Research Site
Madrid, Spain
Switzerland
Research Site
Basel, Switzerland
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Additional Information:

Publications:

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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00358956    
Other Study ID Numbers: D4200C00068
2006-001354-28 ( EudraCT Number )
First Posted: August 1, 2006    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: January 30, 2017
Last Verified: December 2016
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
medullary thyroid cancer
MTC
hereditary medullary thyroid cancer
thyroid cancer
Additional relevant MeSH terms:
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Thyroid Neoplasms
Carcinoma, Neuroendocrine
Carcinoma, Medullary
Multiple Endocrine Neoplasia Type 2a
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Ductal, Lobular, and Medullary
Multiple Endocrine Neoplasia
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn