Recruiting

Study of AZD9574 and Temozolomide for Patients with Advanced Solid Tumors, Including Breast, Ovarian, Pancreatic, and Prostate Cancers

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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 the effects of a new treatment for patients with advanced solid tumors. The study involves a medication called AZD9574, which is being tested both on its own and in combination with other anti-cancer treatments. The diseases being studied include IDH-mutant glioma, a type of brain tumor, and various advanced or relapsed cancers such as HER2-negative breast cancer, ovarian cancer, prostate cancer, and pancreatic cancer. These cancers may have specific genetic mutations like BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

The purpose of the study is to assess the safety and tolerability of AZD9574 in patients with these advanced cancers. Participants will receive the medication in the form of a film-coated tablet taken orally. The study will monitor how the body processes the drug, its effects on the cancer, and any side effects that may occur. Some participants may receive a placebo for comparison. The study will also explore how the drug affects specific biomarkers, which are indicators of how the body is responding to the treatment.

Throughout the study, participants will undergo regular health checks, including blood tests and imaging scans, to track their progress and the impact of the treatment. The study aims to gather information over a period of time to determine the potential benefits and risks of AZD9574 for treating these types of cancers. This research is important for developing new treatment options for patients with advanced solid tumors.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Blood tests and imaging studies may be performed to evaluate the current state of the condition.
Step 2
Treatment initiation
The treatment phase begins with the administration of AZD9574 as a monotherapy or in combination with other anti-cancer agents.
The medication is provided in the form of a film-coated tablet and is taken orally.
Step 3
Dose escalation
The study involves assessing the safety and tolerability of increasing doses of AZD9574.
The dosage is adjusted based on individual response and tolerance, with close monitoring for any side effects.
Step 4
Combination therapy
In some cases, AZD9574 is combined with other medications such as temozolomide, which is administered in the form of a hard capsule taken orally.
The combination aims to enhance treatment efficacy and is tailored to the specific type of cancer being treated.
Step 5
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor the effects of the treatment. This includes blood tests, imaging studies, and assessments of overall health.
Adjustments to the treatment plan may be made based on the results of these evaluations.
Step 6
End of treatment
The treatment phase concludes at the end of the study period or if the patient experiences significant side effects.
A final assessment is conducted to evaluate the overall response to the treatment and to plan any necessary further care.

Who can join the trial?

11 criteria

Provide signed and dated written consent before any study-specific procedures, sampling, and analyses.
Female participants must not breastfeed and must not donate or retrieve eggs for their own use from screening to about 1 month after the last dose of the study treatment.
Non-sterilized male participants who are sexually active with a female partner who can have children must use a condom with spermicide from screening to about 3 months after the last dose of the study treatment.
Be at least 18 years old at the time of screening.
Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2, which means they can perform daily activities with no significant deterioration over the previous 2 weeks.
Have a life expectancy of at least 12 weeks.
Have cancer that is getting worse at the time of joining the study.
Have confirmation through tests (histological or cytological) of advanced cancer that is suitable for the study treatment and meets specific eligibility criteria for the study module.
Have disease that can be evaluated as defined in specific criteria for Part A and Part B of the study.
Have adequate organ and bone marrow function as defined by the study protocol.
Female participants who can have children must have a negative pregnancy test result at screening and before each cycle of study treatment and must use at least one highly effective method of birth control.

Who cannot join the trial?

6 criteria

Patients who do not have the specific types of cancer being studied, such as certain types of brain, breast, ovarian, prostate, or pancreatic cancer.
Patients who do not have the specific genetic mutations being studied, such as changes in the BRCA1, BRCA2, PALB2, RAD51C, or RAD51D genes.
Patients who have a type of breast cancer that has spread to the brain, known as breast cancer with brain metastases.
Patients who are not within the age range specified for the study.
Patients who are not able to safely participate in the study due to other health conditions or factors.
Patients who are part of a vulnerable population that the study is not designed to include.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitari General De Catalunya
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Sant Cugat Del Valles, Spain
Hospital Universitario Quironsalud Madrid
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Pozuelo De Alarcon, Spain
Hospital Universitario Virgen De La Victoria
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Malaga, Spain

Trial locations

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Investigated drugs

AZD9574
is an experimental medication being studied for its potential to treat advanced solid tumors. It is being tested to see how safe and tolerable it is when used alone and in combination with other cancer treatments. Researchers are also looking at how the body processes this medication and its initial effectiveness in fighting cancer.
Anti-cancer Agents
are medications that are used in combination with AZD9574 in this study. These agents are designed to help fight cancer by targeting and killing cancer cells or stopping them from growing. The study aims to see how well these agents work together with AZD9574 to treat advanced malignancies.

What is already known about the treatment

AZD9574 – AZD9574 is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating advanced solid tumors. It is primarily being investigated for use in patients with IDH-mutant glioma and various advanced or relapsed cancers, including breast, ovarian, prostate, and pancreatic cancers, particularly those with specific genetic mutations like BRCA1, BRCA2, PALB2, RAD51C, and RAD51D. The medication works by targeting specific molecular pathways involved in cancer cell growth and survival, potentially inhibiting tumor progression. AZD9574 is classified as an investigational anti-cancer agent, and its development is focused on understanding its pharmacokinetics and pharmacodynamics in combination with other cancer treatments.

Investigated diseases

IDH-mutant glioma
This is a type of brain tumor characterized by mutations in the isocitrate dehydrogenase (IDH) gene. These mutations lead to abnormal cell growth in the brain. Gliomas can vary in their aggressiveness, with some growing slowly and others more rapidly. The presence of IDH mutations often indicates a distinct biological behavior compared to gliomas without these mutations. Over time, these tumors can cause symptoms such as headaches, seizures, and neurological deficits depending on their location in the brain.
HER2-negative breast cancer
This form of breast cancer does not have an overexpression of the HER2 protein, which is involved in cell growth. It can be either hormone receptor-positive or triple-negative, affecting treatment options and disease progression. HER2-negative breast cancer can spread to other parts of the body, leading to advanced or relapsed stages. The progression of the disease can vary widely among individuals, with some experiencing slow growth and others more rapid advancement.
Ovarian cancer
This cancer originates in the ovaries and is often detected at an advanced stage due to subtle early symptoms. It can spread to the pelvis and abdomen, leading to more severe symptoms as it progresses. The disease is characterized by the growth of abnormal cells that can invade nearby tissues. Over time, ovarian cancer can cause symptoms such as bloating, pelvic pain, and changes in bowel habits.
Prostate cancer
This is a common cancer in men, originating in the prostate gland. It often grows slowly and may not cause significant symptoms initially. However, as it progresses, it can lead to urinary difficulties, pelvic discomfort, and bone pain if it spreads. The disease can vary in its aggressiveness, with some forms remaining localized and others spreading to other parts of the body.
Pancreatic cancer
This cancer begins in the tissues of the pancreas, an organ involved in digestion and blood sugar regulation. It is often diagnosed at an advanced stage due to a lack of early symptoms. As it progresses, pancreatic cancer can cause abdominal pain, weight loss, and jaundice. The disease is known for its aggressive nature and potential to spread quickly to nearby organs.
BRCA1/BRCA2 mutation-associated cancers
These genetic mutations increase the risk of developing certain cancers, including breast, ovarian, prostate, and pancreatic cancers. The mutations impair the body's ability to repair DNA damage, leading to increased cancer risk. Cancers associated with these mutations can vary in their progression and may require specific management strategies. Over time, they can lead to symptoms related to the specific type of cancer they cause.