A phase II study to investigate the efficacy of RAD001 (Afinitor®, everolimus) in patients with irresectable recurrent or metastatic differentiated, undifferentiated (anaplastic) and medullary thyroid carcinoma - THYRRAD, CRAD001CNL08T

eiden University Medical Center0 sitesJanuary 28, 2010

ConditionsPatients with irresectable recurrent or metastatic differentiated, undifferentiated (anaplastic) and medullary thyroid carcinoma will be treated in a phase II study to investigate the efficacy of RAD001 (Afinitor®, everolimus).

DrugsAfinitor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients with irresectable recurrent or metastatic differentiated, undifferentiated (anaplastic) and medullary thyroid carcinoma will be treated in a phase II study to investigate the efficacy of RAD001 (Afinitor®, everolimus).
Sponsor: eiden University Medical Center
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 28, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

eiden University Medical Center

Eligibility Criteria

Inclusion Criteria

•TARGET POPULATION:
•Patients with differentiated thyroid cancer comprise the main part of this study. A total number of 28 patients with differentiated thyroid cancer will be studied.
•Inclusion Criteria:
•Age \> 18 years
•Karnofsky performance score \> 70%
•Patients with differentiated thyroid carcinoma (i.e. papillary and follicular carcinomas)
•Patients must have undergone total thyroidectomy (and having received thyrosuppressive therapy afterwards)
•Patients with no RaI uptake in tumor as proven by RaI scintigraphy performed after prior RaI therapy
•Patients with insufficient RaI uptake as proven by progression of lesions despite accumulation of RaI
•Patients with a maximum cumulative dosis of RaI

Exclusion Criteria

•Exclusion Criteria:
•Patients receiving chemotherapy, immunotherapy, radiation therapy or any other investigational agent within 4 weeks of the first dose of study drug, or sunitinib and/or sorafenib within 2 weeks of the first dose of RAD001\. Patients must have recovered from effects of prior therapy.
•Patients who have previously received RAD001 or other mTOR inhibitors.
•Patients with known hypersensitivity to RAD001 or other rapamycin analogs (sirolimus, temsirolimus), or to its excipients.
•Patients receiving chronic, systemic treatment with corticosteroids or another
•immunosuppressive agent (except corticosteroids with a daily dosage equivalent to
•prednisone \= 20 mg for adrenal insufficiency). Patients receiving corticosteroids must be on a stable dose for \= 4 weeks prior to the first dose of RAD001\. Topical or inhaled corticosteroids are permitted.
•Patients with an active bleeding diathesis.
•Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g., intra\-thoracic, intra\-abdominal, or intra\-pelvic), open biopsy, or significant traumatic injury, or who have not recovered from the side effects of any of the above.
•Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction \= 6 months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis or severely impaired lung function. Investigation of LVEF can be performed in case of doubt for in/exclusion.