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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

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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 SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteBranson, Missouri  
Research SiteAbilene, Texas