A Phase 2 Open-Label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid Cancer

Amgen Inc.0 个研究点目标入组 160 人开始时间: 2005年7月26日最近更新: 2012年4月3日

研究概览

暂无简介。

•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.

发起方

Amgen Inc.