Study of ONC175
We are looking for patients who have Renal Cancer and would like to participate in a clinical study to test a new potential treatment.
... minute read
Study Lead Organization (sponsor)
Study of ONC175
Recruiting
Choose your location
Karolinska
Sweden 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. ONC175, is a new potential medication, which specifically target cells in the kidney, including cancer cells. In this study, we want to explore how safe and efficient ONC175 is at different dose levels.
Who is this study for?
This study 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 study is to find the dose of ONC175 that is safe and tolerable and to learn about the effects. To take part in this study 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.
What treatments are given in the study?
Investigational Medication: The investigational medication is ONC175.
How it Works: The investigational medication targets cancerous cells in the kidneys and cancer cells that have spread to other parts of the body.
Prescreening question for the ONC175 study
This section is here to help you determine if you qualify to participate in this study. If you are ever unsure about the requirements you should consult with your physician.
- 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.
- Have been diagnosed with any other cancer (there are exceptions to this, and trial doctors will evaluate this before they can join the study).
- Have cancer cells that have spread to the brain (also called “brain metastasis”)
- Be pregnant or breastfeeding.
Are you interested in participating in this study?
The study is being conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital in Sweden.
The study doctor will explain what participating in the study will mean for you. If you agree to join, the study 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 study.
If you are eligible to participate, you will receive ONC175 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 ONC175 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 study 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 study.
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 study is voluntary, and you can leave at any time without it affecting your treatment.
The study includes a Screening Period, a treatment Period (made up of 28-day Cycles), and a Follow-up Period.
Total duration of the study: Around 1 year
Screening
time:
28 days before treatment begins up to the day before treatment starts.
description
Visit 1
A screening visit with tests to make sure you meet the study requirements and that participation is safe. Includes a physical exam, blood tests, vital signs and other tests.
Treatment
description
Visit 2-9
During each treatment cycle, you will have 8 clinic visits. In addition, X-ray scans will be done every 8–12 weeks after your first dose to check how the treatment is working.
Follow-Up
description
Visit 10
A visit at the clinic 2 months after the last day of treatment and then a phone call with site staff every 3 months until the study ends.
Contact this study today!
Have questions about our clinical studies or need more information on how to participate. Our team is here to provide you with all the details you need. Don’t hesitate to reach out to us today!
Frequently Asked Questions
Potential benefits
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Tumor Reduction: The investigational medication may shrink your tumor.
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Longer Survival: If the investigational medication is successful, you might live longer or have better tumor control.
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Helping Future Patients: Even if the investigational medication doesn’t help you, the information gathered from the trial can help doctors develop new treatments that might benefit future patients with similar conditions.
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