Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
Treatment Schedule: Everolimus will be administered at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Tablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
National Cancer Institute
Bratislava, Slovakia
Response rate
according RECIST criteria version 1.1
Time frame: 36 month
Favorable response rate
complete response with chemotherapy and/or surgery, partial response marker negative.
Time frame: 36 month
Clinical benefit rate
(complete and partial response and stable disease \> 6 months)
Time frame: 36 month
Progression-free survival
expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate
Time frame: 36 month
Toxicity
Time frame: 36 month
Frequency of grade III and IV adverse events
Time frame: 36 month
Association between clinical outcome and biomarkers
Time frame: 36 month
Serum tumor markers response
\>90% decline of AFP and/or HCG
Time frame: 36 month
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