Klinische Studie
Cabozantinib in patients with locally advanced or metastatic Urothelial Cell carcinoma who have progressed after cisplatin-based chemotherapy and anti-PD-1/PD-L1 therapy or after anti-PD-1/PD-L1 therapy only(CabUC)The primary objective of the trial is to investigate if cabozantinib monotherapy shows an objective clinical response in patients with urothelial cell carcinoma
Krankheitsentität(en)
Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase II
StudientypInterventionsstudiePhase II
Wesentliche Einschlusskriterien1. Written informed consent
2. Age 18
3. Life expectancy ≥ 10 weeks
4. Patients must be able to swallow intact tablets.
5. Patients with histology/cytology confirmed urothelial carcinoma (UC) including mixed pathology with predominantly UC, with locally advanced (T4b) or metastatic (lymph node or visceral) UC
Wesentliche AusschlusskriterienRadiation, chemotherapy, or other anti-cancer therapy <4 weeks prior to enrollment in the study.
2. Patients previously treated with small molecule tyrosine kinase inhibitors.
3. Systemic treatment with radionuclides <4 weeks prior to enrollment in the study, and subjects with clinically relevant ongoing complications from prior radiation therapy.
4. Abdominal surgery <10 weeks prior to enrollment in the study. Complete wound healing must be observed at least 10 days prior to enrollment, and patients should not have relevant ongoing complications at study enrollment.
5. Inadequate organ and bone marrow function as evidenced by:
Hemoglobin <9.0 g/dL;
HbA1c > 8%;
Absolute neutrophil count <1.5 x 109/L;
Platelet count <100 x 109/L;
Fasting serum triglycerides > 2.5 x ULN and total cholesterol > 300 mg/dL. Lipid-lowering medication is allowed;
AST/SGOT and/or ALT/SGPT ≥3.0 x ULN (upper limit of normal);
Total bilirubin >1.5 x ULN, for subjects with Gilbert’s disease > 3 mg/dL;
Serum creatinine >2.0 x ULN;
Creatinine clearance ≤ 30 mL/min (Cockroft-Gault formula);
PT or INR or PTT ≥ 1.3 x ULN.
Urine protein-to-creatinine ratio (UPCR) > 1 mg/mg (> 113.2 mg/mmol)
StatusStudie beendet
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de