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A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Thyroid Cancer

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Trial Information

A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer


Inclusion Criteria:

- Histologically confirmed locally advanced or metastatic thyroid
cancer - Measurable disease - Normal blood pressure (if history of hypertension, blood
pressure must be controlled with medication) - Evidence of disease progression within 6
months before starting study (for differentiated thyroid cancer subjects) - Evidence of
disease progression within 6 months before starting study OR symptomatic disease (for
medullary thyroid cancer subjects) - Not a candidate for surgical resection, external beam
radiotherapy, radioiodine therapy, or other local therapy - At least 18 years of age
Exclusion Criteria: - Undifferentiated/anaplastic thyroid cancer - Untreated or
symptomatic brain metastases - Prior malignancy, unless cured with treatment and no
evidence of disease for greater than or equal to 3 years before starting study (history of
thyroid cancer, in situ cervical cancer, or basal cell cancer of skin are exceptions) -
Myocardial infarction or any unstable cardiac condition (e.g., congestive heart failure,
unstable angina) within 1 year before starting study - Arterial thrombosis or deep vein
thrombosis within 1 year before starting study

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 (complete response and partial response) as defined by modifed RECIST

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Austria: Bundesamt fur Sicherheit im Gesundheitswesen

Study ID:

20040273

NCT ID:

NCT00121628

Start Date:

July 2005

Completion Date:

October 2010

Related Keywords:

  • Thyroid Cancer
  • Thyroid cancer
  • Advanced thyroid cancer
  • Metastatic thyroid cancer
  • Medullary thyroid cancer
  • Follicular thyroid cancer
  • Papillary thyroid cancer
  • Hurthle cell thyroid cancer
  • Thyroid cancer treatments
  • Differentiated thyroid cancer and medullary thyroid cancer
  • Thyroid Neoplasms
  • Thyroid Diseases

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