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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
oral once daily tablet
Research Site
San Francisco, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
New York, New York, United States
Research Site
Durham, North Carolina, United States
Objective Response Rate
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.
Time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Progression Free Survival
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.
Time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Duration of Objective Response
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.
Time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Disease Control Rate
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.
Time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Biochemical Response Calcitonin (CTN)
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).
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
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Research Site
Houston, Texas, United States
Research Site
Villejuif, France
Symptomatic Response
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.
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.
World Health Organisation (WHO) Performance Status
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)
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.