RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

This study is looking into a new medication called AZD9574 for people whose advanced solid cancers have either come back or gotten worse. We want to understand how safe it is, how well people tolerate it, and how their bodies process the drug. We'll also be checking for any signs that the drug is effective at treating the cancer, both when given on its own and when combined with other existing cancer treatments. The study is divided into different parts, looking at various cancer types, including ovarian, breast, pancreatic, and prostate cancer, and a specific type of brain tumour. Approximately 695 people will take part.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

695

Start

24 Jun 2022

Estimated completion

13 Oct 2027

Advanced Solid Malignancies

What is this study about?

This research is exploring a new treatment, AZD9574, for various advanced solid cancers. These are cancers that have spread or continued to grow despite previous treatments. The main goals are to understand how safe this new drug is, what side effects people might experience, and how the body handles it. We also want to see if it shows any early signs of shrinking tumours or stopping their growth.

The study involves giving AZD9574 in different ways: sometimes on its own, and sometimes combined with other established cancer drugs like Temozolomide. Researchers will carefully increase the dose in some parts of the study to find the safest and most effective amount. This is a common way to test new drugs, starting with small groups of people and then moving to larger groups once the safety is clearer. Some specific parts of the study will focus on particular types of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, and a brain tumour.

About 695 people will take part in this study. It's designed in several 'modules', with each module looking at different aspects of the treatment or different groups of patients. One module, for example, will specifically look at breast cancer patients with certain genetic changes, while another will examine patients with a specific type of brain tumour. There's even a small part of the study focused on how food or other medications might affect how AZD9574 works in the body.

Key takeaways

Tests new drug AZD9574 for advanced solid cancers.
Aims to assess safety, how body handles the drug, and early effectiveness.
Includes AZD9574 alone and in combination with other anti-cancer drugs.
Around 695 people will participate, across various cancer types.
Participation involves regular visits, tests, and closely monitored treatment.

Who may be eligible?

To be considered for this study, you would generally need to have a type of advanced solid cancer that has grown or returned after previous treatments. Your general health and ability to carry out daily activities, as assessed by a doctor, should be stable over the past two weeks.

You would also need to have healthy enough organs and bone marrow, as checked by blood tests. For specific parts of the study, particularly those involving AZD9574 on its own, your cancer would need to be of a certain type, such as ovarian, breast, pancreatic, or prostate cancer, and show specific genetic changes that doctors believe might respond to this type of drug. Your cancer also needs to be measurable, meaning doctors can see and track its size.

Some parts of the study have additional requirements, for example, for certain breast cancer types with specific genetic mutations, or for people who can follow specific eating instructions related to taking the medication. The study is open to both men and women aged 18 to 130 years old.

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.

Is my cancer considered 'advanced' or has it spread?
Has my cancer returned or progressed after previous treatments?
Is my general health currently stable?
Am I aged 18 or over?
Do I have any specific genetic changes in my cancer (for some study parts)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to receive AZD9574 either on its own or with other anti-cancer drugs. The study involves regular visits to the hospital or clinic for assessments. These will include physical examinations, blood tests, and scans (like MRI) to monitor your general health and see how the cancer is responding to treatment. Importantly, a small number of participants will have specific investigations looking at how food or stomach acid-reducing medications might affect the study drug. During the study, researchers will carefully monitor your health for any side effects and adjust your treatment if necessary. You will be asked to follow specific instructions regarding your medication and possibly your diet. The duration of treatment will vary depending on the specific module you are in and how you respond to the treatment, with some modules lasting up to 12 cycles. There will also be follow-up appointments after your treatment ends to continue monitoring your health.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new drug, AZD9574, helps manage your cancer when other treatments haven't worked. However, like all medications, AZD9574 has potential risks, including side effects that can range from mild to serious. These will be fully explained to you by the study team before you decide to take part. You will also have additional monitoring not usually part of standard care. It's very important to remember that joining a clinical trial is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (32)

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

Research Site
Verified postcode
La Jolla, United States· Withdrawn
Research Site
Verified postcode
Los Angeles, United States· Recruiting
Research Site
Verified postcode
San Francisco, United States· Recruiting
Research Site
Verified postcode
Chicago, United States· Recruiting
Research Site
Verified postcode
Boston, United States· Recruiting
Research Site
Verified postcode
New York, United States· Recruiting
Research Site
Verified postcode
New York, United States· Recruiting
Research Site
Verified postcode
Portland, United States· Completed
Research Site
Verified postcode
Houston, United States· Recruiting
Research Site
Verified postcode
San Antonio, United States· Not yet recruiting
Research Site
Verified postcode
Richmond, United States· Withdrawn
Research Site
Verified postcode
Darlinghurst, Australia· Recruiting

Common questions

What does 'advanced solid malignancies' mean?

This refers to cancers that have grown or spread to other parts of the body, and are not blood cancers.

What is AZD9574?

It's a new medication being tested to see if it can help treat advanced cancers.

What are 'Phase 1' and 'Phase 2' studies?

Phase 1 studies primarily check for safety and the right dose, while Phase 2 studies look at how effective the drug is and continue to monitor safety.

Why are there different 'modules' in the study?

The modules allow researchers to test the drug in different ways, like on its own or with other medicines, and in different types of cancer.

Can I still eat normally if I'm on the study?

Some parts of the study require specific dietary instructions, such as eating a high-fat meal or fasting, to see how food affects the drug.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.