Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma (NCT05287945) | Clinical Trial Compass
RecruitingPhase 1/2
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
United States, Portugal, Sweden75 participantsStarted 2023-08-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0.
Timeframe: Through study completion, approximately 1 year
2
Changes in arterial blood pressure measurements
Timeframe: Through study completion, approximately 1 year
3
Changes in pulse rate measurements
Timeframe: Through study completion, approximately 1 year
4
Changes in respiratory rate measurements
Timeframe: Through study completion, approximately 1 year
5
Changes in temperature measurements
Timeframe: Through study completion, approximately 1 year
6
Changes in physical examination findings
Timeframe: Through study completion, approximately 1 year
7
Maximum tolerable dose of orellanine
Timeframe: Through study completion, approximately 1 year
. Neutrophils ≥1.5 × 10\^9/L, without growth factor stimulation within 3 weeks prior to the blood test;
Exclusion criteria
. Diagnosis of any other malignancy within 2 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, superficial melanoma, or carcinoma in situ of the breast or of the cervix, or low grade (Gleason 7 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g., surgery, radiation, or castration)
. Radiotherapy within 2 weeks before first dose.
. Immuno-oncology therapy (IO) given in the last six (6) months prior to enrolment
. Other systemic anti-cancer therapy within 2 weeks before first dose.
. Has not recovered from AEs due to prior anti-cancer medications to at least grade 1 by CTCAE version 5.0 (except for alopecia and grade 2 neuropathy).
. Has received any other investigational product within 4 weeks before first dose.
. Pregnant or breastfeeding women.
. Uncontrolled medical condition including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, or would, in the opinion of the investigator, place the patient at increased risk.