Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
This research trial is investigating a new medication called AZD5305, both on its own and in combination with other anti-cancer drugs. The study is for people with advanced solid cancers, including various types like ovarian, breast, pancreatic, prostate, and lung cancer. The main goals are to find out if AZD5305 is safe to use, how well people tolerate it, and if it shows any positive effects against their cancer. This type of study, known as a Phase 1/2a trial, focuses on understanding these key aspects of a new treatment in its earlier stages of development.
At a glance
What is this study about?
This research study is exploring a new treatment option for people living with advanced solid cancers. Advanced solid cancers are those that have spread from where they started or are difficult to treat with standard therapies. The new drug, called AZD5305, is part of a group of medications known as PARP inhibitors, which work by targeting specific weaknesses in cancer cells to stop them from growing and dividing. This trial will test AZD5305 by itself and in combination with other established cancer medicines like paclitaxel and carboplatin, as well as newer anti-cancer agents.
The main purpose of this study is to gather important information about AZD5305. Firstly, the researchers want to understand if it's safe for people to take and what side effects might occur. This is known as assessing 'safety' and 'tolerability.' Secondly, they want to see if the drug has any anti-cancer activity, meaning if it can help to slow down or shrink the cancer. This information is crucial for deciding if AZD5305 should be studied further in larger trials.
This is a Phase 1/2a study, which means it's an early-stage clinical trial. Phase 1 trials primarily focus on safety and finding the right dose, while Phase 2a trials start to look at how effective the treatment might be. The 'modular' and 'open-label' design means the study is organised into different parts, allowing researchers to explore various drug combinations and that both patients and their doctors will know which treatment is being given.
Key takeaways
- This study is testing a new drug, AZD5305, for advanced solid cancers.
- It aims to find out if AZD5305 is safe, tolerable, and effective.
- The drug may be given alone or with other anti-cancer treatments.
- Participants will have various types of advanced solid cancers, including ovarian, breast, and lung cancer.
- Close medical monitoring will be provided throughout the study.
Who may be eligible?
To be able to take part in this study, you would generally need to be at least 18 years old and have an advanced solid cancer that has been confirmed by a doctor. Your cancer should also be progressing, meaning it's continuing to grow, and you should be considered well enough for study treatment, typically meaning you can perform your daily activities with minimal difficulty. You would also need to have good organ function, including healthy bone marrow, as determined by standard medical tests.
There are also specific requirements depending on which part of the study you might join. For some parts, you might have had a specific type of previous anti-cancer treatment called a PARPi, while for other parts, having had such a treatment would mean you couldn't join. You would also need to provide a sample of your tumour tissue, if possible, for further analysis.
On the other hand, you would not be able to join if you've recently had certain other treatments, such as particular types of chemotherapy or investigational drugs, within a few weeks of starting the study. Other reasons for not being able to join include taking strong medications that interact with the study drug, having had major surgery recently, or needing high doses of steroids. All these rules are in place to ensure your safety during the study and that the results are as clear as possible.
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 at least 18 years old?
- Do you have an advanced solid cancer that is currently progressing?
- Are you generally well enough for treatment, with good organ function?
- Have you discussed your previous treatments with the study team to see if they fit the criteria?
- Are you able to provide a tumour sample if required?
What does participation involve?
If you decide to take part in this study, you would receive the study drug, AZD5305, which is taken by mouth, either on its own or alongside other anti-cancer medications. You would have regular appointments at the hospital for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These assessments are crucial for the research team to understand the drug's safety and effectiveness. The exact number and frequency of visits, as well as the types of tests, would be explained in detail by the study team, as they can vary depending on which part of the trial you are in. Throughout your participation, you would be closely monitored by a team of doctors and nurses. The total duration of your participation would depend on how your body responds to the treatment and the study's specific design, but it typically involves an initial treatment phase followed by a monitoring period.
Potential risks and benefits
Locations (68)
- Research SiteVerified postcodeBoston, United States
- Research SiteVerified postcodeBoston, United States
- Research SiteVerified postcodeNew York, United States
- Research SiteVerified postcodeOklahoma City, United States
- Research SiteVerified postcodeHouston, United States
- Research SiteVerified postcodeHeidelberg, Australia
- Research SiteVerified postcodeMelbourne, Australia
- Research SiteVerified postcodeVancouver, Canada
- Research SiteVerified postcodeToronto, Canada
- Research SiteVerified postcodeMontreal, Canada
- Research SiteVerified postcodeMontreal, Canada
- Research SiteVerified postcodeBeijing, China
Common questions
What is a 'solid malignancy'?
A 'solid malignancy' is a medical term for a solid tumour, which is a lump of abnormal tissue that doesn't contain cysts or liquid areas. Many types of cancer, like breast, lung, and prostate cancer, form solid tumours.
What does 'advanced' cancer mean in this study?
'Advanced' cancer means that the cancer has spread from where it started to other parts of the body, or it's at a stage where standard treatments might not be fully effective.
What is a 'PARP inhibitor'?
A PARP inhibitor is a type of cancer drug that works by blocking a protein called PARP, which helps cancer cells repair their DNA. By blocking this, it makes it harder for cancer cells to survive and grow.
What is the difference between a Phase 1 and Phase 2 study?
Phase 1 studies primarily check if a new drug is safe and help find the right dose. Phase 2 studies then investigate if the drug actually works against the cancer, while still monitoring safety.
Will I know if I'm getting the new drug or a standard treatment?
Yes, this is an 'open-label' study, which means both you and your doctors will know exactly which treatment you are receiving.
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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