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Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.

Phase 2
18 Years
Open (Enrolling)
Germ Cell Tumor

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Trial Information

Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.

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.

Inclusion Criteria:

1. Signed written informed consent

2. Men aged 18 years or older

3. ECOG performance status: 0-2,

4. Histological confirmed extracranial primary germ cell cancer, seminoma, or

5. Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on
sequential measurement or biopsy-proven unresectable germ cell cancer

6. Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients
non fit enough for high-dose chemotherapy

7. Primary mediastinal GCTs in first relapse

8. Patient's disease must not be amenable to cure with either surgery or chemotherapy in
the opinion of investigator,

9. Measurable disease radiological

10. Adequate hematologic function defined by WBC > 4000/mm3, platelet count > 100
000/mm3 and hemoglobin level > 9g/dl.

11. Adequate liver function defined by a total bilirubin level < 1.5 ULN, and ALT, AST <
2,5 ULN and adequate renal function defined by serum creatinine ≤ 1.5 x ULN.

12. At least 2 weeks must have elapsed since the last radiotherapy and/or chemotherapy
before study entry,

13. At least 4 weeks must have elapsed since the last major surgery

14. Complete recovery from prior surgery, and/or reduction of all adverse events from
previous systemic therapy or radiotherapy to grade 1,

15. Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule, -

Exclusion Criteria:

1. Patients who do not fit inclusion criteria,

2. Other prior malignancy except successfully treated non melanoma skin cancer

3. Prior treatment with mTOR inhibitor

4. No other concurrent approved or investigational anticancer treatment, including
surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or

5. Female patients,

6. Patients infected by the Human Immunodeficiency Virus (HIV),

7. Patients with other severe acute or chronic medical condition, or laboratory
abnormality that would impair, in the judgment of investigator, excess risk
associated with study treatment, or which, in judgment of the investigator, would
make the patient inappropriate for entry into this study,

8. Inability of oral intake, or drug absorption (e.g. malabsorption syndrome)

9. Hypersensitivity to any compound of the drug,

10. Sexually active men not using effective birth control if their partners are women of
child-bearing potential.

11. Patients with active CNS metastasis

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

according RECIST criteria version 1.1

Outcome Time Frame:

36 month

Safety Issue:


Principal Investigator

Jozef Mardiak, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


Slovakia: State Institute for Drug Control

Study ID:




Start Date:

November 2011

Completion Date:

December 2014

Related Keywords:

  • Germ Cell Tumor
  • refractory germ cell cancer
  • everolimus
  • Testicular Neoplasms
  • Neoplasms, Germ Cell and Embryonal