Carcinoma, Renal Cell Clinical Trial
Official title:
A Phase I/II, Open-Label, Single-Arm Study on Safety, Tolerability and Anti-Tumour Efficacy of Orellanine Treatment in Patients With Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
A phase I/II, open-label, study to determine the safety and preliminary efficacy of orellanine in patients with metastatic clear-cell or papillary renal carcinoma. The study will include an intra-patient dose escalation phase, followed by a dose expansion phase.
This is an open, non-controlled, phase I/II study evaluating the safety, tolerability, and anti-tumor efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal carcinoma. The study will include up to 50 patients. The study will consist of 2 phases: an intra-patient dose escalation phase, followed by a dose exposure phase. A safety review will be completed by the Data Review Committee after every dose in every patient in the dose escalation phase to review pharmacokinetics, safety and tolerability data. In the exposure part of the study, up to 30 additional patients will be recruited and treated at increased dose exposure to better characterize drug safety, tolerability, and preliminary efficacy. ;
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