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