NCT05287945 – English
ContactWe are looking for patients who have Renal Cancer and would like to participate in a clinical trial to test a new potential treatment
We are looking for a better way to treat metastatic Renal Cell Cancer (RCC), which means cancer cells have spread from the kidneys to other parts of the body. For those with metastatic RCC, disease outcome is poor and available therapies may help relieve symptoms but not cure the disease. Orellanine, is a new potential medication, which specifically target cells in the kidney, including cancer cells. In this trial, we want to explore how safe and efficient orellanine is at different dose levels.
This trial will include adults with metastatic renal cell cancer who have end-stage renal disease (ESRD), the advanced stage of kidney disease where kidneys could no longer function on their own. All participants should be on hemodialysis (a process wherein a machine, instead of the kidneys, cleanses the blood) for at least 3 months.
The main goal of the trial is to find the dose of orellanine that is safe and tolerable and to learn about the effects. To take part in this trial may stop or slow your disease progression, but it’s not for sure that you will have any benefits. However, findings from this study may help other patients in the future.
Sponsor of the trial is Oncorena AB
Who can participate?
Participants must
- Are at least 18 years old.
- Have a metastatic renal cell cancer that is identified as either “clear cell renal cell cancer” (ccRCC) or “papillary renal cell cancer” (pRCC).
- Have severe kidney disease where the kidneys can no longer function on their own. All participants must be on hemodialysis (a process where a machine, instead of the kidneys, cleans the blood) for at least 3 months.
Participants must not
- Have been diagnosed with any other cancer (there are exceptions to this, and trial doctors will evaluate this before they can join the trial).
- Have cancer cells that have spread to the brain (also called “brain metastasis”)
- Be pregnant or breastfeeding.
If you are interested in joining this trial
The study is being conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital in Sweden.
The trial doctor will explain what participating in the trial will mean for you. If you agree to join, the trial doctors and other site staff will perform examinations and ask you questions about your disease, your medical history, and the medications you are taking to make sure you are eligible to take part in the trial.
If you are eligible to participate, you will receive orellanin as an infusion over 30 minutes every four weeks. You need to come to the hospital the day before the start of the treatment to receive hemodialysis. On the day of treatment, you will receive an infusion of orellanin over 30 minutes (the medicine is administered through a needle inserted into a vein in the arm). The treatment is divided into treatment cycles of 28 days each.
Participants will need to visit the study clinic regularly during each cycle. During study visits, the trial doctors will:
- Give you a physical examination and check your health
- Collect laboratory samples, like blood
- Perform imaging tests to check your tumor status
Details about these visits and the types of tests that will be performed will be explained to you fully before you decide whether you want to join the trial.
As the study may involve travel, hotel accommodation, guest dialysis, and other additional expenses, a concierge function is ready to assist with practical arrangements. The sponsor is responsible for all these extra costs associated with the study.
The study is approved by the Swedish Ethical Review Board and the Swedish Medical Product Agency. Participation in a clinical trial is voluntary, and you can leave at any time without it affecting your treatment.
Frequently asked questions
What is a clinical trial?
Through clinical research, scientists and doctors can determine whether a new medical drug, is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary.
What does a typical clinical trial look like?
Clinical trials help determine the safety and effectiveness of treatments. A research plan, also called a protocol, is created before the trial starts. A clinical trial may compare a new treatment to a standard treatment option that is already available, to a placebo (an identical-looking treatment with no active ingredient), or to no intervention at all. Before you decide to join a clinical trial, the trial team will explain all of the trial details.
What is a Phase 1/2 clinical trial?
When new drugs are being studied as a possible treatment for patients with a disease, they are tested in stages, or “phases.” If a drug is successful in Phase 1, it moves to Phase 2.
If it is successful in Phase 2, it moves to Phase 3. Researchers may conduct a Phase 1 trial to learn more about how a drug (or drug combination) behaves in the body, to find a safe dose, or to test a new formulation of a drug (such as a pill versus injection). Phase 1 studies are usually conducted with a small number of participants.
In a Phase 2 trial, a drug is usually studied in a larger group. Researchers conduct Phase 2 trials to study how well a drug works and to learn more about the safety and tolerability of a drug, including any side effects people might have when they take it.
Phase 1/2 trials combine these goals into a single, more efficient trial design. If a drug meets certain standards for safety during the first part of the trial (Phase 1), it can move immediately to the next part where its effects as a treatment can be studied in a larger group of people (Phase 2).