Refractory histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma germ cell tumours
Conditions
Interventions
Trade Name: Gemcirena 38 mg/ml plv ifo 1 x 1000 mg
Product Name: Gemcirena 38 mg/ml plv ifo 1 x 1000 mg
Product Code: C79325
Pharmaceutical Form: Powder for concentrate for dispersion for infusion
INN
Sponsors
Národný onkologický ústav
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent 2) Men aged 18 years or older 3) ECOG performance status: 0-1, 4) Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma 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 radiologically 10) Adequate hematologic function defined by ANC > 1500/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl. 11) Adequate liver function defined by a total bilirubin level 1.5 × ULN is allowed if no symptoms of compromised liver function are present 12) Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance > 50 ml/min. Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creatinine (mg/dl)] 13) At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry, 14) At least 4 weeks must have elapsed since the last major surgery 15) Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1, 16) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 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 43 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: 1) Patients who do not fit inclusion criteria 2) Other prior malignancy except successfully treated nonmelanoma skin cancer 3) Prior PARP1 inhibitor 4) Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy 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 absorbtion (e.g. malabsorption syndrome) 9) Hypersensitivity to any compound of the drug 10) Sexually active men not using highly effective birth control if their partners are women of child-bearing potential 11) Patients with history of or current CNS metastasis 12) Patients with history of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy (as measured by 12-months progression-free survival) of gemcitabine, carboplatin and VELIPARIB (ABT-888) in patients with refractory germ cell tumors (GCTs).;Secondary Objective: To describe the favorable response rate, time to progression and toxic effects of VELIPARIB (ABT-888) given with gemcitabine, carboplatin in patients with refractory metastatic germ cell cancer. ;Primary end point(s): 12-months progression-free survival rate;Timepoint(s) of evaluation of this end point: 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate Overall survival Toxicity Frequency of grade III and IV adverse events Association between clinical outcome and biomarkers ;Timepoint(s) of evaluation of this end point: 12 month | — |
Countries
Slovakia
Contacts
Public ContactDepartment of Clinical Trial
Národný onkologický ústav
Outcome results
None listed