Phase 2
N=19
A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer
Thyroid Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00358956 ↗Enrolled (actual)
19
Serious AEs
21.1%
Results posted
Aug 2012
Primary outcome: Primary: Objective Response Rate (ORR) — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ZD6474 (vandetanib) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genzyme, a Sanofi Company
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
3 | — |
| SECONDARY Progression-Free Survival (PFS) |
16.2 | — |
| SECONDARY Disease Control Rate (DCR) |
13 | — |
| SECONDARY World Heath Organization (WHO) Performance Status |
— | — |
| SECONDARY Symptomatic Response |
— | — |
| SECONDARY Biochemical Response Calcitonin (CTN ) |
3 | — |
| SECONDARY Biochemical Response Carcinoembryonic Antigen CEA) |
1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00358956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.