Study of AZD9574 and Temozolomide for Patients with Advanced Solid Tumors, Including Breast, Ovarian, Pancreatic, and Prostate Cancers
This clinical trial is investigating a new treatment approach for patients with advanced solid tumors, including IDH-mutant glioma, a specific type of brain tumor. The study is testing an investigational medication called AZD9574, which is being examined both as a standalone treatment and in combination with other anti-cancer medications, including temozolomide.
Main focus and goals: The primary objective of this trial is to assess the safety and tolerability of AZD9574 in patients with advanced cancers. Researchers are particularly interested in understanding how the body processes this medication, monitoring its effects on tumor growth, and identifying any side effects that may occur. The study also aims to explore how the drug affects specific biomarkers, which are biological indicators that help researchers understand how the body is responding to treatment. Throughout the study, participants will undergo regular health assessments, including blood tests and imaging scans, to track their progress and evaluate the treatment's impact.
Investigational drugs: The trial involves AZD9574, an experimental medication being studied for its potential to treat advanced solid tumors. It works by targeting specific molecular pathways involved in cancer cell growth and survival. Some participants will receive AZD9574 alone, while others will receive it in combination with other anti-cancer agents, including temozolomide. AZD9574 is administered as a film-coated tablet taken orally, while temozolomide is given as a hard capsule.
Who can participate (inclusion criteria): To be eligible for this study, participants must be at least 18 years old and have confirmed advanced cancer that is progressing at the time of enrollment. Patients must have adequate organ and bone marrow function as defined by the study protocol, and a life expectancy of at least 12 weeks. They should be able to perform daily activities with minimal limitations, having an ECOG performance status of 0 to 2. Female participants of childbearing potential must have a negative pregnancy test and agree to use effective birth control methods during the study and for at least one month after the last dose. Male participants who are sexually active with partners who can become pregnant must use contraception during treatment and for about three months after the final dose. All participants must provide signed consent before any study procedures begin.
Who cannot participate (exclusion criteria): Patients are not eligible for this trial if they do not have the specific types of cancer being studied, such as IDH-mutant glioma or certain types of breast, ovarian, prostate, or pancreatic cancer. The study also excludes patients who do not have the specific genetic mutations being investigated, including changes in the BRCA1, BRCA2, PALB2, RAD51C, or RAD51D genes. Patients with breast cancer that has spread to the brain are not eligible. Additionally, those who are outside the specified age range or have other health conditions that would make it unsafe to participate are excluded from the study.