A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
This research study is investigating a new medication called AZD1390 in combination with radiation therapy for people with certain types of brain tumors. It's a 'first-in-human' study, meaning this is the first time this specific drug is being given to patients. The main purpose is to understand if AZD1390 is safe and well-tolerated, and to see how the body absorbs, uses, and gets rid of the drug when combined with different radiation treatments. The study involves different groups of patients, each receiving AZD1390 with a specific radiation plan tailored to their type of brain cancer, such as recurrent glioblastoma or primary glioblastoma. This important first step helps doctors learn more about promising new treatments for brain cancer.
At a glance
What is this study about?
This study is a medical research project looking at a new drug called AZD1390. It's specifically for people who have certain types of brain cancer. The main idea is to see how this new drug works when given together with radiation therapy, which is a common cancer treatment. Because this is the first time AZD1390 is being given to people, the most important goal of this study is to find out if it's safe to use and how well people can tolerate it. The researchers also want to understand how the drug moves through the body – how it's absorbed, distributed, and eventually leaves the body.
The study is split into different groups, called 'arms,' and each group is designed to learn something specific. For example, some groups might have patients with glioblastoma that has come back, while others might have patients with a newly diagnosed glioblastoma. Each group will receive AZD1390 along with a different type or schedule of radiation therapy, which is already a standard treatment for their specific condition. By testing different doses of AZD1390 and combining it with various radiation plans, doctors hope to find the safest and most effective ways to use this new drug.
This kind of study, called a Phase 1 study, is a crucial early step in developing new medicines. It helps doctors learn important information about a new drug's safety before it can be studied in more people to see how well it treats the cancer. It's all about gathering vital information meticulously to make sure any new treatment is as safe and helpful as possible for future patients.
Key takeaways
- This is a Phase 1 study testing a new drug (AZD1390) for brain cancer.
- The main goal is to find out if AZD1390 is safe when given with radiation therapy.
- It's the first time AZD1390 is being given to people.
- Different groups of patients with specific brain cancers are included.
- Participation involves close monitoring of health and side effects.
Who may be eligible?
To be considered for this study, you would need to have specific medical conditions and meet certain health criteria. For example, generally, you must be 18 years or older. You'd need to have a confirmed diagnosis of certain brain cancers, such as glioblastoma, either newly diagnosed or if it has come back.
Depending on which part of the study you might join, there are more specific requirements. For instance, if you have recurrent glioblastoma, you would need to have finished your initial radiation treatment at least six months before joining. Your general health and ability to carry out daily activities would also be assessed, usually needing a good performance score.
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?
- Do you have a confirmed diagnosis of glioblastoma or other specific brain tumors?
- Are you able to manage daily activities reasonably well (Karnofsky Performance Score of 60 or higher)?
- Are you able to provide a tissue sample from your tumor?
- For recurrent glioblastoma, has it been at least 6 months since your last radiation therapy?
- Are any seizures you experience well-controlled with medication?
What does participation involve?
If you decide to take part in this study, you would receive the new drug, AZD1390, alongside radiation therapy, just as described in the study plan. The study involves a blend of standard cancer care (like your radiation treatments) with the investigational drug. You would be carefully monitored by the study team throughout, which would include regular visits, blood tests, and scans to check your health, how your body is reacting to the drug, and to see if there are any side effects. The exact number of visits and tests would depend on which part of the study you are in, but the team will explain everything to you in detail. The total length of your participation would involve the treatment period and follow-up appointments.
Potential risks and benefits
Locations (12)
- Research SiteVerified postcodeBoston, United States· Recruiting
- Research SiteVerified postcodeBoston, United States· Recruiting
- Research SiteVerified postcodeNew York, United States· Recruiting
- Research SiteVerified postcodePittsburgh, United States· Recruiting
- Research SiteVerified postcodeRichmond, United States· Recruiting
- Research SiteVerified postcodeChūōku, Japan· Completed
- Research SiteUnverifiedHidaka-shi, Japan· Active not recruiting
- Research SiteVerified postcodeKyoto, Japan· Active not recruiting
- Research SiteVerified postcodeCambridge, United Kingdom· Active not recruiting
- Research SiteVerified postcodeGlasgow, United Kingdom· Completed
- Research SiteVerified postcodeLeeds, United Kingdom· Recruiting
- Research SiteVerified postcodeLondon, United Kingdom· Withdrawn
Common questions
What is AZD1390?
AZD1390 is a new drug being tested in this study. It's an investigational drug, meaning it's not yet approved for general use and doctors are carefully studying how it works.
What does 'Phase 1 study' mean?
A Phase 1 study is usually the first time a new drug is given to people. The main goal is to check for safety, find the right dose, and see how the body handles the medicine, not yet to cure a disease.
Can I still participate if I've had radiation before?
It depends on your specific situation. For some parts of the study, previous radiation might be allowed, especially if it was a while ago or didn't cover the same area. The study team will check your medical history carefully.
Will I still get my usual radiation treatment?
Yes, if you join this study, you will receive standard radiation therapy that your doctors would normally recommend for your type of brain cancer. The AZD1390 drug is given in addition to this standard treatment.
Where is this study taking place?
This study is happening in several countries, including the United States, the United Kingdom, and Japan. You can ask the study team for specific locations near you.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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