A Phase I/II, Open label, Single arm Study on Safety, Tolerability and Anti-Tumour Efficacy of Orellanine Treatment in Patients with Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
Study Identifier:
ONC001-CL-001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
To evaluate orellanine in dialysis patients with metastatic kidney cancer.
To evaluate safety and tolerability, as well as antitumor activity in different doses of orellanine in patients with metastatic kidney cancer.
To study safety, tolerability, pharmacokinetics and signs of anti-tumour effects in treatment with a synthetic form of orellanine.
To determine the safety and preliminary efficacy of orellanine in patients with metastatic clear-cell or papillary renal carcinoma.
To determine the maximum tolerable dose (MTD) of orellanine in patients with metastatic clear cell or papillary RCC and end stage renal disease who are on chronic haemodialysis and who have failed standard of care treatment.
Dose escalation phase: To determine MTD or a dose causing complete response (CR).
Dose expansion phase: To better characterize safety, tolerability and primary efficacy.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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: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 metastasesTotal bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 × ULNFor 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 treatment.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 males and 6 months for females.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, efficacy assessments, laboratory tests, and other study procedures.
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 enrolmentOther 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.QTc interval at baseline of ≥470 msec.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Lisbon
Lisbon, Portugal, 1649-035
Investigator
Andre Mansinho
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Renal