A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
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
2 other identifiers
interventional
19
8 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2006
Longer than P75 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedResults Posted
Study results publicly available
August 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJanuary 30, 2017
December 1, 2016
1.4 years
July 28, 2006
April 27, 2011
December 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
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) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 12 weeks, progressive disease (PD) or NE.
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 (6)
Progression-Free Survival (PFS)
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)
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
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
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 )
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)
- +1 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Research Site
Little Rock, Arkansas, United States
Research Site
Boston, Massachusetts, United States
Research Site
St Leonards, Australia
Research Site
Sherbrooke, Quebec, Canada
Research Site
Pisa, Italy
Research Site
Utrecht, Netherlands
Research Site
Bucharest, Romania
Research Site
Madrid, Spain
Research Site
Basel, Switzerland
Related Publications (1)
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.
PMID: 20371662BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2006
First Posted
August 1, 2006
Study Start
August 1, 2006
Primary Completion
January 1, 2008
Study Completion
May 1, 2014
Last Updated
January 30, 2017
Results First Posted
August 31, 2012
Record last verified: 2016-12