Carcinoma, Renal Cell study: Orellanine
Official title Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT05287945
What this study is testing
What is Orellanine?
Orellanine is an investigational medicine being studied as a potential treatment for metastatic kidney cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether orellanine is safe and may help treat metastatic clear‑cell or papillary kidney cancer after other treatments have stopped working.
- Who it's for
- You may be able to join if you have advanced kidney cancer, have kidney failure, and are on regular hemodialysis.
- What's involved
- You would receive orellanine treatment and have regular check‑ups and tests to see how you feel and how the cancer responds.
- Time commitment
- The study lasts about 6 months, with several clinic visits and blood tests during that time.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has provided written informed consent.
- Has a diagnosis of histologically confirmed advanced ccRCC or pRCC.
- 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.
You likely can't join if
- Diagnosis of any other malignancy within 2 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer...
- 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.
See the full eligibility 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.
- 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.
- 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...
- 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 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, how well it works assessments, laboratory tests, and other study procedures.
- 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...
- 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...
- QTc interval at baseline of ≥470 msec.
The study team makes the final eligibility decision.
Where it is enrolling
- Orange, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- Houston, Texas, United States
- Villejuif, France
- Lisbon, Portugal
- Lleida, Spain
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orange, California, United States; Palo Alto, California, United States; San Francisco, California, United States; St Louis, Missouri, United States; Buffalo, New York, United States; Houston, Texas, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.