A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer
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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 |
- Objective Response Rate (complete response and partial response) as defined by modifed RECIST
- 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 |
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
More Information
Additional Information:
Publications:
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: | September 17, 2012 |
| 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 May 16, 2013