5287945
Last Update Posted: 2024-06-24
Recruiting
All Genders accepted | 18 Years + |
50 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Study of Orellanine in 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.
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.
Eligibility
Relevant conditions:
Carcinoma, Renal Cell
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
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Contact Information
Overall Contact
Data sourced from ClinicalTrials.gov