Thyroid Cancer
Conditions
Keywords
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
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.
Interventions
DRUGAMG 706
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (complete response and partial response) as defined by modified RECIST | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
| Changes in tumor markers | — |
| overall survival time | — |
| time to response | — |
| Duration of response | — |
| 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) | — |
| Tumour Related Symptoms (medullary thyroid cancer arm) | — |
Outcome results
None listed