To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
This important study is investigating a new medication called inavolisib. It's designed for people who have advanced breast cancer, meaning it has spread, or other solid tumours that are also advanced. The main goals are to find out if the medicine is safe to use and how well people tolerate it. Researchers will also be checking how the body processes the medication. For people with breast cancer, they will look at inavolisib on its own and also when it's given alongside other common hormone and targeted therapies. This is a very early stage of research, often called a 'Phase 1' study, where new medicines are given to humans for the first time to learn fundamental information about them.
At a glance
What is this study about?
This study is focused on a new medicine called inavolisib. It's for adults who have advanced breast cancer or other types of solid tumours that have spread. When doctors say 'advanced' or 'metastatic,' it means the cancer has grown or spread to other parts of the body.
The main aim of this research is to understand the new medicine better. This involves checking if it's safe to use and if people can take it without too many side effects – this is what 'safety and tolerability' means. Researchers also want to see how the body handles the medicine, for example, how much stays in the blood and for how long. This is called 'pharmacokinetics'.
For people with breast cancer, the study will test inavolisib in two ways: first, by itself, and then in combination with other established treatments that target specific cancer cells or hormones. This is an early-stage study, often called a Phase 1 study. This means it's one of the first times this new medicine is being given to people, so researchers can gather crucial information about how it works and if it could be a promising treatment.
Key takeaways
- This study is testing a new medicine called inavolisib.
- It's for adults with advanced breast cancer or other solid tumours.
- Researchers want to know if it's safe and how the body processes it.
- It's an early-stage (Phase 1) study.
- Participation involves regular clinic visits for tests and monitoring.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. Both men and women can take part. The study is for people who have been diagnosed with advanced breast cancer or another type of advanced solid cancer – meaning your cancer has spread.
There will be specific health checks and tests to make sure that taking part is safe for you. For example, doctors will need to review your overall health, any other medical conditions you have, and the treatments you've had in the past.
It's important to discuss your full medical history with the study doctors. They will be able to tell you if you meet all the necessary requirements to participate in this particular research.
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.
- Am I at least 18 years old?
- Do I have advanced breast cancer or another advanced solid tumour?
- Am I willing to attend regular hospital or clinic appointments?
- Am I open to taking a new, experimental medicine?
- Do I understand that this is an early-stage study which focuses on safety?
What does participation involve?
If you join this study, you'll be given the new medicine, inavolisib, either on its own or with other treatments if you have breast cancer. You'll need to attend regular visits at a clinic or hospital. These visits will involve blood tests to check how the medicine is affecting your body and to monitor for any side effects. You might also have scans or other examinations to see how your cancer is responding.
During treatment, you'll be closely monitored by a team of doctors and nurses. The number of visits and the types of tests will gradually reduce over time. After you stop taking the study medicine, you'll usually have follow-up appointments to check on your health. The total duration of your participation, including follow-up, will be explained fully by the study team, but it will involve several months of active involvement and monitoring.
Potential risks and benefits
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Common questions
What does 'advanced' cancer mean?
Advanced (or metastatic) cancer means the cancer has grown beyond where it started and may have spread to other parts of your body.
What is a 'Phase 1' study?
A Phase 1 study is a very early stage of research, where a new medicine is given to people for the first time to primarily check its safety and how the body handles it.
What is 'inavolisib'?
Inavolisib is the name of the new experimental medicine being tested in this study. It's not yet approved for general use.
Will I know if I'm getting the new medicine or a different treatment?
In studies like this, you will usually know if you are receiving the new study drug or a combination. The study team will explain everything before you agree to take part.
Can I stop taking part if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting 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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