Overview

This trial is active, not recruiting.

Condition thyroid cancer
Treatment zd6474 (vandetanib)
Phase phase 2
Sponsor AstraZeneca
Start date November 2004
End date February 2008
Trial size 40 participants
Trial identifier NCT00098345, D4200C00008

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Daily oral dose of Caprelsa (vandetanib) 300mg
zd6474 (vandetanib) Caprelsa™ (vandetanib)
oral once daily tablet

Primary Outcomes

Measure
Objective Response Rate
time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.

Secondary Outcomes

Measure
Progression Free Survival
time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Duration of Objective Response
time frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Disease Control Rate
time frame: Pre-dose and every 12 weeks up to RECIST progression 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
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.
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.