Active not recruitingPHASE1INTERVENTIONAL

AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies

This study is looking at a new medicine called AZD6244, which comes in a capsule form. It's for people who have advanced solid cancers that haven't responded to usual treatments. The main goals are to find out if the capsule is safe, if people can take it without too many side effects, and how it moves through and leaves the body. This is a very early-stage study, meaning it's one of the first times this specific capsule form is being tested in people. Researchers hope to learn a lot about the drug's basic properties to decide if it can be studied further in the future. It's a way to explore new potential treatments for cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

08 Mar 2007

Estimated completion

26 Mar 2027

Tumor Cancer

What is this study about?

This study is testing a new medicine, an oral capsule called AZD6244, for people who have advanced cancers. When we say 'advanced solid malignancies,' we mean cancers that have grown or spread, and they are not responding to the standard treatments usually given. The main aim of this study is to understand more about this new medicine.

Specifically, the researchers want to see how safe the AZD6244 capsule is and what side effects it might cause. They also want to understand how your body handles the medicine – how it's absorbed, distributed, processed, and removed. This stage of research is called 'Phase 1,' which means it's one of the first times this particular form of the drug is being tested in a small group of people. It's a crucial step to make sure any new medicine is safe enough to be studied further.

The findings from this study will help doctors decide if AZD6244 has the potential to be a helpful treatment for certain cancers in the future. It's about exploring new options when standard treatments are no longer effective.

Key takeaways

It's a study for advanced cancers not responding to standard treatments.
The new medicine is called AZD6244, given as a capsule.
The main goals are to check safety and how the body processes the medicine.
It's a 'Phase 1' study, meaning it's an early look at this new treatment.
Participation involves regular clinic visits for monitoring.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, people must have cancer that has sadly not responded to standard treatments. You also need to be generally well enough to take part, as measured by a health score that your doctor will check.

There are also some important points that might mean you can't join. For example, if you've had certain treatments like radiotherapy or chemotherapy very recently (within the last 21 days), or if you have certain brain or spinal problems that aren't stable without medication, you might not be eligible. If you've been in another study involving new medicines in the last 30 days, that would also mean you couldn't take part this time.

Your doctor will carefully review all your health information to see if this study is suitable for you.

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.

Do you have advanced cancer that hasn't responded to standard treatments?
Are you generally well enough according to your doctor's assessment?
Have you not had radiotherapy or chemotherapy in the last 3 weeks?
Do you not have unstable brain or spinal problems requiring steroids/medication?
Have you not participated in another new drug study in the past month?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the AZD6244 medicine in a capsule form. The study will involve regular visits to the clinic so doctors can monitor your health closely, check for any side effects, and see how the medicine is affecting your body. This will include blood tests and other assessments. The exact number of visits, how long each visit lasts, and the total length of the study will be explained in detail by the study team. They will also tell you about any follow-up appointments after you stop taking the medicine.

Potential risks and benefits

Participating in research studies like this can offer some potential benefits, such as access to a new medicine that isn't widely available. However, there's no guarantee the medicine will help your specific condition. There are also potential risks, as any new medicine can cause side effects. These could be mild or, in some cases, more serious. The study team will explain all known and potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
Verified postcode
Aurora, United States
Research Site
Verified postcode
Nijmegen, Netherlands
Research Site
Verified postcode
Utrecht, Netherlands
Research Site
Verified postcode
Sutton, United Kingdom

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid cancers that have not responded to usual treatments.

What is AZD6244?

AZD6244 is a new medicine in a capsule form that is being tested as a potential cancer treatment.

What does 'Phase 1' mean?

Phase 1 means it's an early-stage study, mainly focused on finding out if the new medicine is safe and how the body handles it.

Will this medicine cure my cancer?

This is an early-stage study designed to gather information about the medicine. There's no certainty it will cure your cancer, but it could help researchers learn more.

How long does the study last?

The exact duration of your involvement will be explained by the study team, as it can vary for each participant.