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; MedDRA version: 8.1Level: LLTClassification code 10055107Term: Thyroid cancer metastatic

• Registration Number: EUCTR2005-001618-42-AT
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-21
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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 modified RECIST; ECOG score 0 to 2; systolic blood pressure less than or equal to 145 mm Hg and diastolic blood pressure less than or equal to 85 mm Hg (antihypertensive therapy to achieve these parameters is allowable).
For subjects with medullary thyroid cancer: documented evidence of disease progression within 6 months of study day 1 OR symptomatic disease at the time of screening in the absence of disease progression; not amenable to or refractory to surgical resection, external beam radiation therapy, or other local therapies.
For subjects with differentiated thyroid cancer: documented evidence of disease progression by modified 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

Exclusion Criteria

Untreated or symptomatic brain metastases;
prior malignancy;
myocardial infarction or unstable or uncontrolled cardiac function;
arterial thrombosis or deep vein thrombosis or pulmonary embolism;
history of hemoptysis;
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, or nefazodone;
unable to swallow oral medications;
treatment with immune modulators such as tacrolimus and cyclosporine within 7 days before study day 1.

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 differentiated 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.