Overview

This trial is active, not recruiting.

Condition thyroid cancer
Treatment zd6474 (vandetanib)
Phase phase 2
Sponsor AstraZeneca
Start date August 2006
End date January 2008
Trial size 22 participants
Trial identifier NCT00358956, D4200C00068

Summary

This will be a Phase II, open label study to establish the effect of once-daily oral doses of ZD6474 100mg in subjects with locally advanced or metastatic hereditary medullary thyroid cancer in whom no standard therapeutic option is available.

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)
zd6474 (vandetanib) Caprelsa™
100 mg once daily oral tablet

Primary Outcomes

Measure
Objective Response Rate (ORR)
time frame: RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.

Secondary Outcomes

Measure
Progression-Free Survival (PFS)
time frame: RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.
Disease Control Rate (DCR)
time frame: RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.
World Heath Organization (WHO) Performance Status
time frame: WHO PS assessed at screening (up to 3 weeks prior to first dose), baseline and then every 12 weeks (± 2 weeks), up to and including discontinuation of study treatment.
Symptomatic Response
time frame: Symptomatic diarrhea was assessed using stool frequency diaries. Baseline was established using the average of the 4 days immediately prior to first dose, then weekly until discontinuation of study treatment.
Biochemical Response Calcitonin (CTN )
time frame: Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation Time point(s) at which outcome measure was assessed. (Limit: 255 characters)
Biochemical Response Carcinoembryonic Antigen CEA)
time frame: Blood samples for analysis of CTN were taken at screening (0, 1, 4, and 8 hours to determine the baseline CTN/CEA level) then every 4 weeks until discontinuation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Provision of written informed consent - Previously confirmed histological diagnosis of locally advanced or metastatic hereditary medullary thyroid carcinoma without standard therapeutic options - Aged 18 or over and a life expectancy of more than 12 weeks Exclusion Criteria: - The last dose of prior chemo/radiation received less than 4 weeks before the start of study therapy - Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age, history of arrhythmia

Additional Information

Official title A Phase II, Open-Label Study To Assess The Efficacy and Tolerability of ZD6474 (ZACTIMA™ ) 100 mg Monotherapy In Subjects With Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by AstraZeneca.