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Completed

NCT Number: NCT00098345

Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

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.

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Villejuif, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZD6474 (Vandetanib)

Drug

oral once daily tablet

Other names: Caprelsa™ (vandetanib), SAR390530

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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)

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2008
Study completion
2017
First posted
Dec 8, 2004
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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