Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: December 7, 2004
Last updated: December 12, 2013
Last verified: December 2013
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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:
U.S. FDA Resources
Further study details as provided by AstraZeneca:
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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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)
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||March 2014|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Experimental: Caprelsa (vandetanib) 300 mg
Daily oral dose of Caprelsa (vandetanib) 300mg
Drug: ZD6474 (vandetanib)
oral once daily tablet
Other Name: Caprelsa™ (vandetanib)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098345
|United States, California|
|San Francisco, California, United States|
|United States, Connecticut|
|New Haven, Connecticut, United States|
|United States, Missouri|
|St. Louis, Missouri, United States|
|United States, New York|
|New York, New York, United States|
|United States, North Carolina|
|Durham, North Carolina, United States|
|United States, Texas|
|Houston, Texas, United States|
|Villejuif Cedex, France|
Sponsors and Collaborators
|Study Director:||AstraZeneca ZD6474 Medical Science Director, MD||AstraZeneca|