Everolimus in Refractory Testicular Germ Cell Cancer
|ClinicalTrials.gov Identifier: NCT01466231|
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : January 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Germ Cell Tumor||Drug: Everolimus||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|