Clinical trial NCT00358956: A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Cancer
Keywords: medullary thyroid cancer
MTC
hereditary medullary thyroid cancer
thyroid cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 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)
timeFrame: 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.
measure: Disease Control Rate (DCR)
timeFrame: 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.
measure: World Heath Organization (WHO) Performance Status
timeFrame: 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.
measure: Symptomatic Response
timeFrame: 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.
measure: Biochemical Response Calcitonin (CTN )
timeFrame: 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)
measure: Biochemical Response Carcinoembryonic Antigen CEA)
timeFrame: 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
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: St Leonards
country: Australia
facility: Research Site
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Pisa
country: Italy
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Robinson BG, Paz-Ares L, Krebs A, Vasselli J, Haddad R. Vandetanib (100 mg) in patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Endocrinol Metab. 2010 Jun;95(6):2664-71. doi: 10.1210/jc.2009-2461. Epub 2010 Apr 6.