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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00121628
First received: July 12, 2005
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

The purpose of the study is to determine if AMG 706 will have clinically meaningful anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are not candidates for radioactive iodine therapy or local therapies.


Condition Intervention Phase
Thyroid Cancer
Drug: AMG 706
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Objective Response Rate (complete response and partial response) as defined by modified RECIST

Secondary Outcome Measures:
  • Duration of response
  • Progression Free Survival
  • Changes in tumor markers
  • overall survival time
  • time to response
  • Tumour Related Symptoms (medullary thyroid cancer arm)
  • AMG 706 pharmacokinetic profile
  • patient reported outcome (EQ-5D)
  • Safety Endpoint: Incidence of treatment-emergent adverse events (including all, serious, treatment-related, and each by maximum severity).
  • Pharmacokinetic Enpoint: AMG 706 pharmacokinetic parameters (Cmax, t1/2, AUC0-24,C24)

Enrollment: 184
Study Start Date: July 2005
Study Completion Date: October 2010
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121628

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00121628     History of Changes
Obsolete Identifiers: NCT00331383
Other Study ID Numbers: 20040273
Study First Received: July 12, 2005
Last Updated: October 7, 2013
Health Authority: Austria: Bundesamt fur Sicherheit im Gesundheitswesen
Belgium: Directorate-General for Medicinal Products
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Italy: Local Ethics Committees
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Lakemedelsverket
Switzerland: Local Ethics Committee
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
United States: Food and Drug Administration

Keywords provided by Amgen:
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

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014