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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study to evaluate the addition of an experimental drug, CC-90010, to the usual treatment of brain cancer after surgery

This research study is investigating a new medication called CC-90010. It’s designed for adults who have recently been diagnosed with a serious type of brain cancer called glioblastoma (specifically, WHO Grade IV newly diagnosed glioblastoma). Participants will have already had surgery to remove some or all of their tumour. The main goal is to see if adding this new experimental drug to the usual treatments can make a difference. This is an early-stage study, meaning we're primarily looking at how safe the drug is and how the body reacts to it. The study is open to both men and women aged 18 and over.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Celgene Corp., Celgene Corp.
Enrolment target
216
Start
03 Apr 2024

What is this study about?

This study is looking into whether a new experimental drug, called CC-90010, can be a helpful addition to the treatments people usually receive for a serious type of brain cancer. This particular brain cancer is called glioblastoma, and this study focuses on people who have been diagnosed with it for the first time and have already had surgery to remove their tumour.

Imagine your body's usual defences are trying to fight off an illness, and the doctors are giving you standard treatments to help. This study is like trying to add a new tool (CC-90010) to that defence kit to see if it makes your body's fight more effective or helps the standard treatments work even better. It’s important to remember that CC-90010 is not yet approved for general use, which is why it's called an 'experimental' drug.

The main aim of this early-stage study is to understand more about CC-90010. Researchers want to find out if it's safe for people to take, what side effects it might cause, and how the body processes it. This information is crucial for deciding if this new drug should be studied further in larger groups of people.

Key takeaways

  • This study is for adults with a newly diagnosed, serious type of brain cancer called glioblastoma.
  • It's testing a new experimental drug, CC-90010, alongside standard treatments.
  • The main aim is to check the safety of the new drug and how your body reacts to it (Phase I study).
  • You must have already had surgery to remove some or all of your tumour.
  • Participation involves regular visits, tests, and receiving the experimental drug.
  • You have the right to leave the study at any time.

Who may be eligible?

This study is looking for volunteers who are adults, aged 18 or older. Both men and women can take part.

To be eligible, you must have been recently diagnosed with a specific type of brain cancer called WHO Grade IV glioblastoma. You must also have already had surgery to remove some or all of the tumour. This study is specifically for newly diagnosed cases, not for people whose cancer has returned.

There might be other health conditions or medications that would prevent someone from joining, even if they meet these main criteria. A study doctor would need to review your full medical history to confirm if you are suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been newly diagnosed with WHO Grade IV glioblastoma?
  3. Have you already had surgery (partial or full removal) for your brain tumour?
  4. Are you prepared to receive a new experimental drug in addition to your standard treatment?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. During these visits, you would receive the experimental drug, CC-90010, along with your usual treatments. You would also have various tests, such as blood tests, scans, and physical examinations, to monitor your health, check for any side effects, and see how the treatment is affecting your body. The exact number of visits and tests would be explained to you in detail by the study team. Follow-up appointments would continue for a certain period after your main treatment ends to track your long-term health. The total duration of your participation would depend on the study's design and your individual response.

Potential risks and benefits

Participating in a study like this might offer the potential benefit of accessing a new treatment (CC-90010) that isn't yet widely available, which could potentially help your condition. However, because CC-90010 is an experimental drug, there's a possibility of unknown side effects or that it may not work for you. The study team will carefully monitor you for any potential risks or side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Denmark
  • Unverified
    Sweden
  • Unverified
    Spain
  • Unverified
    Italy
  • Unverified
    Norway
  • Unverified
    Netherlands

Common questions

What does 'experimental drug' mean?

It means the drug is still being tested and is not yet approved for use as a standard treatment. We don't fully know all its effects yet.

What is glioblastoma?

It's a type of fast-growing and serious brain cancer. WHO Grade IV refers to how aggressive the cancer cells are.

Do I stop my current treatment if I join?

No, this study is testing the new drug *in addition to* your usual treatments, not as a replacement.

What is a Phase I study?

It's an early stage of human testing, mainly to check if the drug is safe and to find the right dose. It's not primarily focused on whether it cures the disease.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your ongoing medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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