Open label Phase I Study of Everolimus(RAD001) plus Doxorubicin in advanced progressive and refractory thyroid cancer - THYRADOX

niversitätsklinikum Halle (Saale)0 sites14 target enrollmentDecember 10, 2010

Overview

No summary available.

Registry

who.int

Start Date

December 10, 2010

End Date

May 9, 2017

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversitätsklinikum Halle (Saale)

•1\. Age \= 18
•2\. Histologically or cytologically diagnosed thyroid cancer of follicular origin including papillary, follicular or poorly differentiated (insular or large\-cell) thyroid cancer
•3\. Patients with progressive disease within 3 months according to RECIST\-criteria or symptomatic disease (e.g. dyspnea due lung metastasis or bone pain) at the time of screening in the absence of documented disease progression with no further surgical treatment options and which are refractory or not susceptible to radioiodine treatment and if applicable, are refractory to treatment with sorafenib.
•4\. ECOG performance status \= 2
•5\. Measurable lesion(s) according to RECIST\-criteria v1\.1
•6\. Adequate organ and bone marrow function
•7\. Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment
•8\. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001
•9\. Signed informed consent and willingness and ability to comply with study procedures

•1\. Previously received investigational sorafenib therapy within 4 weeks before enrolment in the study
•2\. Previous conventional chemotherapy or any investigational anticancer therapy other than sorafenib
•3\. Prior therapy with mTOR inhibitors
•4\. Second malignancy or history of malignancy within the last 5 years
•5\. Clinically significant active infection requiring antibiotic or antiretroviral therapy
•6\. Clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
•7\. Medical history of clinically significant pulmonary or cardiovascular disease including chronic heart failure or myocardial infarction within 6 month prior to study enrollment or serious uncontrolled cardiac arrhythmia
•8\. Significant hepatic or hematological abnormality (i.e. transaminase levels \> 2\.5 x ULN, serum bilirubin \> 1\.5 x ULN, hemoglobin \< 9g/dl, platelets \< 120\.000/mm³ or absolute neutrophile count \< 1\.500/mm³)
•9\. Serum creatinine \> 1\.5 x ULN
•10\. Uncontrolled hyperlipidemia : Fasting serum cholesterol \> 300mg/dl or \> 7\.75mmol/l AND fasting triglycerides \> 2\.5 x ULN