An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.
18 Years
N/A
Both
Thyroid Cancer
Trial Information
An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate
Outcome Description:
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) defined according to RECIST 1.0.
Outcome Time Frame:
Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Safety Issue:
No
Principal Investigator
AstraZeneca ZD6474 Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D4200C00008
NCT ID:
NCT00098345
Start Date:
November 2004
Completion Date:
December 2012
Related Keywords:
- Thyroid Cancer
- Caprelsa (vandetanib)
- ZD6474
- Thyroid Neoplasms
- Thyroid Diseases
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Danbury, Connecticut |
| Research Site | Branson, Missouri |
| Research Site | Abilene, Texas |
