A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE)
This research study, called PLANETTE, is investigating new ways to treat advanced cancer that has certain changes in its genes. Researchers are testing two different drugs, AZD6738 and Ceralasertib, either alone or in combination. The main goal is to see if these treatments can effectively shrink tumours and if they are safe for patients. This is a Phase 2 study, meaning it's exploring how well the treatments work and what side effects they might cause. It's open to adults aged 18 and over whose cancer has spread and has specific genetic alterations that the study is focusing on. The study will carefully monitor how patients respond to the drugs, including changes in tumour size and overall health.
At a glance
What is this study about?
This study, called PLANETTE, is a research project designed to explore new treatments for advanced cancer. 'Advanced cancer' means the cancer has spread from where it first started. The 'molecular alterations' mentioned mean that the cancer cells have specific genetic changes that the new treatments aim to target. Researchers believe that by targeting these specific changes, they might be able to more effectively fight the cancer.
The study is testing two drugs, AZD6738 and Ceralasertib. These drugs are part of a type of treatment called 'DNA-damage response agents'. This means they work by interfering with the way cancer cells repair damage to their DNA, making it harder for them to grow and multiply. Researchers want to see if these drugs, used alone or together, can shrink tumours or slow their growth in people with advanced cancer.
This is a 'Phase 2' study. This stage of research focuses on whether a new treatment works and what dose is best, as well as checking for side effects. The results of this study will help doctors understand if these drugs could be a promising new option for certain people with advanced cancer, and if they should be tested in larger studies in the future.
Key takeaways
- The study explores new drugs (AZD6738, Ceralasertib) for advanced cancer.
- It targets cancers with specific genetic changes.
- It's a Phase 2 study, focused on how well the drugs work and their safety.
- Participants will have regular medical checks and scans.
- This study aims to find new treatment options for certain cancer patients.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people whose cancer is considered 'advanced,' meaning it has spread in the body.
Crucially, your cancer must also have certain 'molecular alterations.' This means your cancer cells need to show specific genetic changes that the study drugs are designed to target. Your doctor will be able to perform tests to see if your cancer has these particular changes.
There will also be other health requirements and possibly recent treatment restrictions that your study doctor will discuss with you. These are in place to ensure your safety and that the study results are clear.
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.
- Are you 18 years old or older?
- Has your cancer spread to other parts of your body?
- Have tests shown your cancer has specific genetic changes?
- Are you well enough to participate in a clinical trial?
What does participation involve?
If you decide to take part in this study, you will receive either AZD6738, Ceralasertib, or a combination of both drugs. This will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These scans might include X-rays, CT scans, or MRI scans to measure changes in your tumour size.
You will also have regular checks of your vital signs (such as blood pressure and heart rate), and researchers will collect blood and urine samples to check your general health and how your body is handling the medication. The study will continue for a period, during which you will be closely monitored. Even after treatment finishes, there will be follow-up appointments to track your long-term health and any ongoing effects of the treatment. The total duration of your participation will depend on various factors, which the study team will explain.
Potential risks and benefits
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Common questions
What does 'modular' mean in this study?
It means the study is designed with different parts, or 'modules,' that can investigate different treatments or groups of patients, usually in a flexible way.
What are 'DNA-damage response agents'?
These are drugs that try to stop cancer cells from fixing damage to their DNA, which can help kill the cancer cells.
What does 'RECIST 1.1' mean?
It's a standard set of rules used by doctors to measure cancer tumours on scans and see if they have shrunk, grown, or stayed the same.
What kind of scans will I have?
You'll likely have scans like CT or MRI to measure your tumours. If you have bone cancer, special bone scans might also be used.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, and it will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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