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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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22 April 2013 |
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Main ID: |
EUCTR2005-001618-42-AT |
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Date of registration:
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21/10/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 2 Open-Label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid Cancer
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Scientific title:
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A Phase 2 Open-Label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid Cancer |
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Date of first enrolment:
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25/11/2005 |
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Target sample size:
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160 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001618-42 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Denmark
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Hungary
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Italy
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Locally advanced or metastatic thyroid cancer
MedDRA version: 8.1
Level: LLT
Classification code 10055107
Term: Thyroid cancer metastatic
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Intervention(s)
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Product Name: AMG 706
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: AMG 706-21
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Name: AMG 706
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: AMG 706-21
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Primary end point(s): Objective response rate (complete response and partial response) as defined by modified RECIST.
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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.
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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.
To assess the safety profile of AMG 706 in subjects with locally advanced or metastatic thyroid cancer in each stratum.
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Secondary ID(s)
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2005-001618-42-SE
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20040273
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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