Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma

Inclusion Criteria19

• Has provided written informed consent.
• Has a diagnosis of histologically confirmed advanced ccRCC or pRCC. No conventional therapy is available or considered appropriate by the treating physician or is declined by the patient.
• For patients in the expansion portion of the study only: Measurable disease per RECIST version 1.1 criteria.
• ECOG performance status of 0 - 2.
• Age ≥18 years.
• Life expectancy ≥3 months.
• Has acceptable haematologic laboratory values defined as:
• Neutrophils ≥1.5 × 10\^9/L, without growth factor stimulation within 3 weeks prior to the blood test;
• Platelets ≥100 × 10\^9/L;
• Haemoglobin ≥5.6 mmol/L (\~90 g/L). Use of erythropoietin or blood transfusions are permitted.
• Has acceptable liver laboratory values defined as:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN for patients with liver metastases
• Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \>1.5 × ULN
• For patients diagnosed with Gilbert's syndrome, total bilirubin ≤2 × ULN is acceptable.
• Must be on chronic hemodialysis (on a consistent regimen for the previous three months, with allowance for intermittent treatments as required for volume overload).
• The patient's treating nephrologist and oncologist agree that the prospect of loss of remaining renal function resulting from this treatment will not significantly change the patient's future and chronic dialysis treatment.
• Female patients of child-bearing potential and male patients must agree to use 2 forms of highly effective contraception for the duration of study treatment and after the last dose of orellanine for at least 3 months for males and 6 months for females.
• For females of child-bearing potential, a negative serum pregnancy test at screening.
• Patients who are willing and able to comply with travel requirements, scheduled visits, treatment schedule, efficacy assessments, laboratory tests, and other study procedures.