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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.

Register:	EUCTR
Last refreshed on:	3 April 2012
Main ID:	EUCTR2005-001618-42-BE
Date of registration:	26/07/2005
Prospective Registration:	Yes
Primary sponsor:	Amgen Inc.
Public title:	A Phase 2 Open-Label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid Cancer
Scientific title:	A Phase 2 Open-Label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid Cancer
Date of first enrolment:	23/01/2006
Target sample size:	160
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001618-42
Study type:	Interventional clinical trial of medicinal product
Study design:	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:
Phase:

Countries of recruitment
Belgium	Denmark	Hungary	Italy	Sweden

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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 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

Exclusion criteria:
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.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Locally advanced or metastatic thyroid cancer

Intervention(s)

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-

Primary Outcome(s)

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.

Primary end point(s): Objective response rate (complete response and partial response) as defined by modified RECIST.

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.

Secondary Outcome(s)

Secondary ID(s)

20040273

2005-001618-42-SE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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