A Phase 2 Open-Label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid Cancer
- Conditions
- ocally advanced or metastatic thyroid cancer
- Registration Number
- EUCTR2005-001618-42-BE
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
At least 18 years of age; provide written consent; histologically documented locally advanced or metastatic thyroid cancer (excluding undifferentiated/anaplastic thyroid cancer and thyroid lymphomas); presence of at least 1 measurable lesion by RECIST; ECOG score 0 to 2; systolic blood pressure less than or equalt to 145 mm Hg and diastolic blood pressure less than or equalt to 85 mm Hg (may be on stable anti-hypertensive medication).
For subjects with medullary thyroid cancer: documented evidence of disease progression within 6 months of study day 1 OR symptomatic disease in the absence of progression; not amenable to or refractory to surgical resection, external beam radiation therapy, or other local therapies.
For subjects with non- medullary thyroid cancer: Documented evidence of disease progression by RECIST within 6 months of study day 1; not amenable to or refractory to surgical resection, external beam radiation therapy, radioiodine therapy, or other local therapies.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Untreated or symptomatic brain metastases; prior malignancy; myocardial infarction or unstable or uncontrolled cardiac function; arterial thrombosis or deep vein thrombosis; history of hemoptysis or evidence of transmural invasion of the trachea or esophagus; previous exposure to AMG 706, other tyrosine kinase inhibitors of rearranged during transfection gene (RET) or vascular endothelial growth factor receptor (VEGFR); treatment with: St. John’s Wort or any herbal therapy containing St. John’s Wort, coumarin anticoagulants, rifampin, phenobarbital, ketoconazole, itraconazole, clarithromycin, erythromycin, HIV protease inhibitors, cyclosporine, tacrolimus, or nefazodone: unable to swallow oral medications.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of AMG 706 on the objective response rate (complete response and partial response) in subjects with locally advanced or metastatic thyroid cancer in each of 2 strata: medullary thyroid cancer and non-medullary thyroid cancer.;Secondary Objective: To determine the effect of AMG 706 on duration of response, tumor-related symptoms (medullary thyroid cancer only), and progression-free survival in each stratum.<br>To assess the safety profile of AMG 706 in subjects with locally advanced or metastatic thyroid cancer in each stratum.;Primary end point(s): Objective response rate (complete response and partial response) as defined by modified RECIST.
- Secondary Outcome Measures
Name Time Method