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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thyroid Cancer

Intervention / Treatment
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* Drug: AMG 706


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AMG 706|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (complete response and partial response) as defined by modified RECIST |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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