A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121628
• Other study ID #: 20040273
• Status: Completed
• Phase: Phase 2
• First received: July 12, 2005
• Last updated: October 7, 2013
• Start date: July 2005
• Est. completion date: October 2010

Study information

• Verified date: October 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt fur Sicherheit im GesundheitswesenBelgium: Directorate-General for Medicinal ProductsDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyItaly: Local Ethics CommitteesItaly: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: LakemedelsverketSwitzerland: Local Ethics CommitteeSwitzerland: Swissmedic (Swiss Agency for Therapeutic Products)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if AMG 706 will have clinically meaningful anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are not candidates for radioactive iodine therapy or local therapies.

Other known NCT identifiers

• NCT00331383

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: October 2010
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: - Histologically confirmed locally advanced or metastatic thyroid cancer - Measurable disease - Normal blood pressure (if history of hypertension, blood pressure must be controlled with medication) - Evidence of disease progression within 6 months before starting study (for differentiated thyroid cancer subjects) - Evidence of disease progression within 6 months before starting study OR symptomatic disease (for medullary thyroid cancer subjects) - Not a candidate for surgical resection, external beam radiotherapy, radioiodine therapy, or other local therapy - At least 18 years of age Exclusion Criteria: - Undifferentiated/anaplastic thyroid cancer - Untreated or symptomatic brain metastases - Prior malignancy, unless cured with treatment and no evidence of disease for greater than or equal to 3 years before starting study (history of thyroid cancer, in situ cervical cancer, or basal cell cancer of skin are exceptions) - Myocardial infarction or any unstable cardiac condition (e.g., congestive heart failure, unstable angina) within 1 year before starting study - Arterial thrombosis or deep vein thrombosis within 1 year before starting study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• AMG 706

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Sherman SI, Wirth LJ, Droz JP, Hofmann M, Bastholt L, Martins RG, Licitra L, Eschenberg MJ, Sun YN, Juan T, Stepan DE, Schlumberger MJ; Motesanib Thyroid Cancer Study Group. Motesanib diphosphate in progressive differentiated thyroid cancer. N Engl J Med. 2008 Jul 3;359(1):31-42. doi: 10.1056/NEJMoa075853. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (complete response and partial response) as defined by modified RECIST
Secondary	Duration of response
Secondary	Progression Free Survival
Secondary	Changes in tumor markers
Secondary	overall survival time
Secondary	time to response
Secondary	Tumour Related Symptoms (medullary thyroid cancer arm)
Secondary	AMG 706 pharmacokinetic profile
Secondary	patient reported outcome (EQ-5D)
Secondary	Safety Endpoint: Incidence of treatment-emergent adverse events (including all, serious, treatment-related, and each by maximum severity).
Secondary	Pharmacokinetic Enpoint: AMG 706 pharmacokinetic parameters (Cmax, t1/2, AUC0-24,C24)

External Links

•   AmgenTrials clinical trials website