Clinical Trial Details
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NCT02115165 : A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors
PhasePhase 2
AgesMin: 15 Years Max: N/A
Inclusion Criteria:

- Male patients aged 15 years or older

- Evidence of advanced NSGCT documented either by pathology or by elevated tumor
markers (AFP or hCG) and a compatible clinical presentation

- Primary site located in either the testis, the retroperitoneum or the mediastinum

- Progressive disease after at least 2 lines of chemotherapy for advanced NSGCT (ie,
non-stage I)

- In case of brain metastases, confirm that patients should be stable / controlled with
corticosteroid/anti seizures agents

- No other progressive carcinoma within previous the 5 years, except for basal-cell
carcinoma of the skin

- Life expectancy >/= 3 months

- Adequate hematologic function :

- Hemoglobin >/= 10.0 g/dL

- Absolute neutrophil count >/= 1.5 x 10 ^ 9/L,

- Platelet count >/= 100 x 10 ^ 9/L,

- Adequate organ function

- Serum creatinine < 1.5 x ULN. If serum creatinine 1.0 - 1.5 x ULN, creatinine
clearance calculated (or measured) according to CKD-EPI formula (see Appendix B) > 60

- Bilirubin
- Information delivered to patient and informed consent form signed by the patient or
his legal representative

- Patient affiliated to a social security system or beneficiary of the same

Exclusion Criteria:

- Patients receiving an investigational drug within 4 weeks prior to enrolment

- Previous radiotherapy within 4 weeks prior to enrolment

- Serious uncontrolled concurrent medical illness

- History of severe hypersensitivity reaction (>/= grade 3) to polysorbate 80
containing drugs or to other taxanes

- Concurrent or planned treatment with strong inhibitors or strong inducers of
cytochrome P450 3A4/5 (see Appendix A). A one week wash-out period is necessary for
patients who are already on these treatments.

- Patient with reproductive potential not implementing accepted and effective method of
contraception for up to 6 months after the last dose of cabazitaxel.

- Active Grade >/= 3 peripheral neuropathy
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