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New treatment option for Carcinoma, Renal Cell
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, given as an infusion into a vein, being studied as a potential treatment for carcinoma, renal cell.
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
- 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.
- 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. No conventional therapy is available or considered appropriate by the treating...
- 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.
- Has acceptable haematologic laboratory values defined as:
- 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.
- Has acceptable liver laboratory values defined as:
- 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's taking place
- Palo Alto, California, United States
- St Louis, Missouri, United States
- Houston, Texas, United States
- Lisbon, Portugal
- 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 - 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?
Study sites include Palo Alto, California, United States; St Louis, Missouri, United States; Houston, Texas, United States; Lisbon, Portugal; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.