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Study on the Safety of AZD8421 Alone or with Drug Combination for Patients with Advanced Breast Cancer and High-Grade Ovarian Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for certain types of advanced cancers, specifically ER-positive HER2-negative advanced breast cancer and high-grade serous ovarian cancer. The study will explore the effects of a new medication called AZD8421, which is being tested both on its own and in combination with other cancer-fighting drugs. The main goal is to understand how safe and tolerable AZD8421 is for patients, and to determine the best dose to use in future studies.

Participants in the study will receive AZD8421 in the form of a film-coated tablet, taken orally. Some participants may also receive other medications, such as Palbociclib, Abemaciclib, Ribociclib, or Zoladex, which are also used to treat cancer. The study will monitor how the body processes these medications and will look for any side effects or changes in health. The study will also include a placebo group to compare the effects of the medications.

The trial will take place over a period of time, during which participants will have regular check-ups and tests to monitor their health and the effects of the treatment. These tests may include imaging scans like MRI or CT scans to assess the size and progression of tumors. The study aims to gather important information that could help improve treatment options for people with these types of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be required to provide informed consent. This includes agreeing to the submission of tumor tissue samples and compliance with study requirements.
Participants must meet specific criteria, such as being female, aged 18 or older, and having advanced solid tumors with prior therapy.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the participant's health status. This includes measuring lesions using imaging techniques like CT or MRI.
The participant's performance status and life expectancy will be assessed to ensure eligibility.
Step 3
Treatment phase
The treatment phase involves administering the investigational drug AZD8421 either alone or in combination with other medications.
The drug is taken orally in the form of film-coated tablets. The dosage and frequency will be determined based on the study protocol.
Step 4
Monitoring and follow-up
Participants will undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes checking for any adverse effects and changes in clinical parameters.
Follow-up assessments will be conducted to evaluate the response to treatment and any changes in tumor size.
Step 5
Completion of study
Upon completion of the study, participants will have a final assessment to determine the overall impact of the treatment.
The study is estimated to end by May 31, 2025, with recruitment starting on December 8, 2023.

Who can join the trial?

10 criteria

Participant must be 18 years of age or older at the time of signing the informed consent form.
Must provide consent to submit a sample of their previous tumor tissue, and this tissue must be available.
Participants must be female.
Participants with advanced solid tumors must have received previous treatment suitable for their type and stage of cancer, or the study must be considered the best option for their next treatment based on how they responded to and tolerated previous therapy.
Must have cancer that has spread or returned locally and have evidence of the disease getting worse after the last treatment before starting the study medication.
Must have an ECOG/WHO performance status of 0 to 1, which means they are fully active or have some symptoms but do not need bed rest, and must have a minimum life expectancy of 12 weeks.
Must have at least one tumor that can be measured or assessed accurately at the start and can be checked again using CT, MRI, X-ray, or clinical examination. Tumors in the bone that are only blastic (a type of bone lesion) are not considered assessable.
Female participants who can have children must agree to use one highly effective method of birth control.
Must be capable of giving signed informed consent, which means they understand and agree to follow the study's requirements and restrictions.
Must provide signed and dated written consent for optional genetic research before collecting samples for genetic studies that support the Genomic Initiative.

Who cannot join the trial?

3 criteria

Patients who do not have **ER+ HER2- advanced breast cancer** or **high-grade serious ovarian cancer (HGSOC)** cannot participate. **ER+ HER2-** refers to a type of breast cancer that is positive for estrogen receptors and negative for human epidermal growth factor receptor 2. **High-grade serious ovarian cancer (HGSOC)** is a severe form of ovarian cancer.
Only **female** patients are eligible, so male patients cannot participate.
Patients who are considered part of a **vulnerable population** are not eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

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Hospital Universitario De Navarra
Pamplona, Spain
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Hospital Vall d’Hebron
Barcelona, Spain

Trial locations

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Investigated drugs

AZD8421
is an experimental medication being studied for its potential to treat advanced or metastatic solid tumors. The trial aims to understand how safe and tolerable this medication is when used alone. Researchers are also looking to find the best dose that can be used in future studies. This medication is being tested to see if it can help stop or slow down the growth of cancer cells.
AZD8421 in combination with other anti-cancer drugs
is also being studied in this trial. The goal is to see if using AZD8421 together with other medications can be more effective in treating certain types of cancer. The study will help determine the safety and best dosage when AZD8421 is used alongside other treatments. This combination approach aims to enhance the overall effectiveness of cancer therapy.

What is already known about the treatment

AZD8421 – This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating certain types of advanced or metastatic solid tumors, specifically ER+ HER2- advanced breast cancer and high-grade serious ovarian cancer. It is in the early stages of research, with ongoing studies to determine the appropriate dosage and potential side effects. AZD8421 is designed to target specific pathways involved in cancer cell growth and survival, although the exact molecular mechanism is still under investigation. It falls under the pharmacological classification of targeted cancer therapies, aiming to interfere with cancer cell proliferation.

Investigated diseases

Advanced Breast Cancer
This type of cancer occurs when breast cancer cells spread beyond the breast to other parts of the body. It is characterized by the presence of estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) markers. The disease progresses as cancer cells grow and invade nearby tissues or spread to distant organs. Symptoms may include lumps in the breast, changes in breast shape, and skin dimpling. Over time, it can lead to more severe symptoms as it affects other body systems. The progression can vary greatly among individuals.
High-Grade Serous Ovarian Cancer (HGSOC)
This is a type of ovarian cancer known for its aggressive nature and rapid progression. It originates in the epithelial cells of the ovary and is often diagnosed at an advanced stage. The disease progresses as cancer cells grow and spread to the pelvic region and beyond. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. As the disease advances, it can affect other organs and lead to more pronounced symptoms. The progression rate can differ among patients.