Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| everolimus 10 mg po daily | Experimental | everolimus 10 mg po daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Tablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | according RECIST criteria version 1.1 | 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable response rate | complete response with chemotherapy and/or surgery, partial response marker negative. | 36 month |
| Clinical benefit rate | (complete and partial response and stable disease > 6 months) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jozef Mardiak, Prof | National Cancer Institute (NCI) | Principal Investigator |
| Michal Mego, Ass.prof. | National Cancer Institute, Slovakia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Bratislava | 83310 | Slovakia |
Not provided
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 36 month |
| Progression-free survival | expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate | 36 month |
| Toxicity | 36 month |
| Frequency of grade III and IV adverse events | 36 month |
| Association between clinical outcome and biomarkers | 36 month |
| Serum tumor markers response | >90% decline of AFP and/or HCG | 36 month |