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Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: December 7, 2004
Last updated: August 24, 2016
Last verified: August 2016
The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.

Condition Intervention Phase
Thyroid Cancer
Drug: ZD6474 (vandetanib)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]
    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) defined according to RECIST 1.0.

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]
    Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.

  • Duration of Objective Response [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]
    Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.

  • Disease Control Rate [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ]
    Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.

  • Biochemical Response Calcitonin (CTN) [ Time Frame: Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation ]
    A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).

  • Symptomatic Response [ Time Frame: Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug. ]
    Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.

  • World Health Organisation (WHO) Performance Status [ Time Frame: Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated. ]
    Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)

Enrollment: 40
Study Start Date: November 2004
Estimated Study Completion Date: December 2019
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caprelsa (vandetanib) 300 mg
Daily oral dose of Caprelsa (vandetanib) 300mg
Drug: ZD6474 (vandetanib)
oral once daily tablet
Other Names:
  • Caprelsa™ (vandetanib)
  • SAR390530


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Locally advanced or hereditary medullary thyroid cancer
  • Signed informed consent
  • One or more measurable lesions

Exclusion Criteria:

  • Brain metastases or spinal cord compression
  • Specific laboratory ranges
  • Specific heart problems
  • Prior chemotherapy and/or radiation therapy
  • Participation in other trials within 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00098345

United States, California
Research Site
San Francisco, California, United States
United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
Villejuif Cedex, France
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00098345     History of Changes
Other Study ID Numbers: D4200C00008
LPS14954 ( Other Identifier: Sanofi )
Study First Received: December 7, 2004
Results First Received: April 27, 2011
Last Updated: August 24, 2016

Keywords provided by Sanofi:
Caprelsa (vandetanib)

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms processed this record on May 25, 2017