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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Amgen

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

Original Primary Outcome:

Current Secondary Outcome:

  • 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)


Original Secondary Outcome:

Information By: Amgen

Dates:
Date Received: July 12, 2005
Date Started: July 2005
Date Completion:
Last Updated: October 7, 2013
Last Verified: October 2013