Dornase alfa for Germ cell cancer

Inclusion criteria

• {"criterion_text":"- Signed written informed consent\n- Adequate hematologic function defined by ANC > 1500/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl.\n- Adequate liver function defined by a total bilirubin level < 1.5 ULN, and ALT, AST < 3 ULN or < 5 in case of liver metastases. For subjects with Gilbert's syndrome bilirubin > 1.5 × ULN is allowed if no symptoms of compromised liver function are present.\n- Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance > 50 ml/min. Cockcroft formula: CLcr = [(140-age) x weight (Kg)]/[72 x creat (mg/dl)].\n- At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry.\n- At least 4 weeks must have elapsed since the last major surgery.\n- Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1.\n- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n- Male patients with a female partner of childbearing potential who agree to use an effective method of contraception (condom) and a highly effective method of contraception by their female partner during the study and 6 months after the last study treatment intake.\n- Adult men aged 18 years or older.\n- ECOG performance status: 0-1.\n- Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma.\n- Rising serum markers (i.e., alfa-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer.\n- Multiple relapsed/refractory GCTs (at least 2 lines of previous chemotherapy) and/or patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy.\n- Primary mediastinal GCTs in first relapse.\n- Patient’s disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator.\n- RECIST 1.1 measurable disease."}

Exclusion criteria

• {"criterion_text":"- Patients who do not fit inclusion criteria.\n- Other prior malignancy except successfully treated nonmelanoma skin cancer.\n- Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy.\n- Female patients.\n- 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.\n- Hypersensitivity to any compound of the drugs, severe known allergies or intolerance to other recombinant protein products obtained from Chinese hamster ovary cells according to Investigatorś decision.\n- Known participation in another clinical trial investigating a drug and/or medical product in the last 30 days or 5 half-lives of the investigational drug and/or medicinal product (whichever is longer)."}

Primary endpoints

• {"endpoint_text":"- 12-week progression-free survival (intent-to-treat population)","definition_or_measurement_approach":"Progression-free survival measured at 12 weeks in the intent-to-treat population (PFS at 12 weeks)."}

Secondary endpoints

• {"endpoint_text":"- Overall response rate (ORR) by RECIST 1.1 and tumor markers (AFP, HCG, LDH)","definition_or_measurement_approach":"ORR assessed by RECIST 1.1 and by changes in tumor markers AFP, HCG, LDH."}
• {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":"Time from treatment start to disease progression or death."}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Time from treatment start to death from any cause."}
• {"endpoint_text":"- Toxicity","definition_or_measurement_approach":"Assessment of adverse events and toxic effects (grade per standard toxicity criteria)."}
• {"endpoint_text":"- Frequency of grade III and IV adverse events","definition_or_measurement_approach":"Incidence rate of grade 3 and 4 adverse events during study treatment."}
• {"endpoint_text":"- Association between clinical outcome and biomarkers (exploratory analysis)","definition_or_measurement_approach":"Exploratory analysis correlating clinical outcomes with biomarker measurements."}

Slovakia

Earliest CTIS Part Ii Submission Date

11-06-2025

Latest Decision Or Authorization Date

05-08-2025

Processing Time Days

55

Number Of Sites

1

Number Of Participants

33

Primary sponsor

Full Name

Narodny Onkologicky Ustav

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Slovakia