Everolimus in Refractory Testicular Germ Cell Cancer
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.|
- Response rate [ Time Frame: 36 month ]according RECIST criteria version 1.1
- Favorable response rate [ Time Frame: 36 month ]complete response with chemotherapy and/or surgery, partial response marker negative.
- Clinical benefit rate [ Time Frame: 36 month ](complete and partial response and stable disease > 6 months)
- Progression-free survival [ Time Frame: 36 month ]expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate
- 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 [ Time Frame: 36 month ]>90% decline of AFP and/or HCG
|Study Start Date:||November 2011|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: everolimus 10 mg po daily
everolimus 10 mg po daily
Tablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
Other Name: Afinitor
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466231
|National Cancer Institute|
|Bratislava, Slovakia, 83310|
|Principal Investigator:||Jozef Mardiak, Prof||National Cancer Institute (NCI)|
|Study Chair:||Michal Mego, Ass.prof.||National Cancer Institute, Slovakia|