Phase 2
N=30
Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
Thyroid Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00098345 ↗Enrolled (actual)
30
Serious AEs
46.7%
Results posted
May 2011
Primary outcome: Primary: Objective Response Rate — 6 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
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
6 | — |
| SECONDARY Progression Free Survival |
27.9 | — |
| SECONDARY Duration of Objective Response |
310.5 | — |
| SECONDARY Disease Control Rate |
22 | — |
| SECONDARY Biochemical Response Calcitonin (CTN) |
24 | — |
| SECONDARY Symptomatic Response |
— | — |
| SECONDARY World Health Organisation (WHO) Performance Status |
4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00098345). 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.