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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


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

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Trial Information

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


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

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 (ORR)

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) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE.

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Peter Langmuir, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00068

NCT ID:

NCT00358956

Start Date:

August 2006

Completion Date:

December 2012

Related Keywords:

  • Thyroid Cancer
  • medullary thyroid cancer
  • MTC
  • hereditary medullary thyroid cancer
  • thyroid cancer
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

Research SiteBentonville, Arkansas  
Research SiteBeverly, Massachusetts