Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
- Registration Number
- NCT05287945
- Lead Sponsor
- Oncorena AB
- 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.
- Detailed Description
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 phase I will consist of 2 parts: an intra-patient dose escalation part, followed by a dose exposure part.. In phase II, up to 30 additional patients will be recruited and treated to better characterize drug safety, tolerability, and preliminary efficacy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Orellanine Orellanine Orellanine administered intravenously
- Primary Outcome Measures
Name Time Method Changes in arterial blood pressure measurements Through study completion, approximately 1 year Changes in temperature measurements Through study completion, approximately 1 year Maximum tolerable dose of orellanine Through study completion, approximately 1 year Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0. Through study completion, approximately 1 year Changes in physical examination findings Through study completion, approximately 1 year Changes in pulse rate measurements Through study completion, approximately 1 year Changes in respiratory rate measurements Through study completion, approximately 1 year
- Secondary Outcome Measures
Name Time Method Area under the curve extrapolated to infinity Through study completion, approximately 1 year. Efficacy of orellanine based on time to tumor response Through study completion, approximately 1 year. Efficacy of orellanine based on best overall response Through study completion, approximately 1 year. Maximum plasma concentration Through study completion, approximately 1 year. Partial area under the curve Through study completion, approximately 1 year. Terminal half-life Through study completion, approximately 1 year. Dose proportionality Through study completion, approximately 1 year. Time to maximum plasma concentration Through study completion, approximately 1 year. Total body clearance Through study completion, approximately 1 year. Volume of distribution Through study completion, approximately 1 year.
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden