Cisplatin-resistant germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum. MedDRA version: 17.0 Level: PT Classification code 10055103 Term: Testicular cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Jevtana
Product Name: jevtana
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Sponsors
Oslo University Hospital - Cancer Department
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Male patients = 18 years old -Histologically verified metastatic GCC (germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum) -Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different platin-based regimens -ECOG Performance Status (PS): 0-2 -Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 29 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Systemic antitumor treatment within 21 days before study entry -Simultaneous radiotherapy to the only target lesion -Patients with unstable angina pectoris, myocardial infarction = 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias -Patients with an active or uncontrolled infection -Patients who have a history of another primary malignancy and are off treatment for = 3 years, with the exception of non-melanoma skin cancer -Active infection requiring systemic antibiotic-, anti-viral-, or antifungal medication -Neuropathy = Grade 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of cabazitaxel as monotherapy for the treatment of germ cell cancer. Efficacy is defined as objective responses according to RECIST 1.1.;Secondary Objective: Disease control rate (SD + PR + CR); Progression-free survival; Overall survival; Safety profile; Change of serum tumor markers.;Primary end point(s): Objective response rate (ORR);Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety profile /Adverse Events (AE);Disease control rate (SD + PR + CR); Progression-free survival (PFS) - time from inclusion to the date of disease progression or death from any cause;Overall survival (OS) - time from inclusion to the date of death from any cause;Change of serum tumormarkers (AFP, beta-betaHCG, LDH).;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Denmark, Italy, Norway, Sweden
Contacts
Public ContactCentro di Coordinamento Studi IRST
IRCCS IRST
Outcome results
None listed