NCT05287945 Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
| NCT ID | NCT05287945 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Oncorena AB |
| Condition | Carcinoma, Renal Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-08-04 |
| Primary Completion | 2027-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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 who have failed standard-of-care therapy. All participants must have end-stage kidney disease and be receiving stable chronic hemodialysis.
Eligibility Criteria
Inclusion criteria: 1. Has provided written informed consent. 2. 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. 3. For patients in the expansion portion of the study only: Measurable disease per RECIST version 1.1 criteria. 4. ECOG performance status of 0 - 2. 5. Age ≥18 years. 6. Life expectancy ≥3 months. 7. Has acceptable haematologic laboratory values defined as: 1. Neutrophils ≥1.5 × 10\^9/L, without growth factor stimulation within 3 weeks prior to the blood test; 2. Platelets ≥100 × 10\^9/L; 3. Haemoglobin ≥5.6 mmol/L (\~90 g/L). Use of erythropoietin or blood transfusions are permitted. 8. Has acceptable liver laboratory values defined as: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN for patients with liver metastases 2. Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with to