Metastases to biliary tract Trials in Disease

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. The study focuses on testing an experimental medication called AZD9574, both alone and in combination with other anti-cancer treatments, including temozolomide. The trial is being conducted in Sweden and Spain.

Main inclusion criteria: To participate in this trial, patients must be at least 18 years old and have advanced cancer that is progressing at the time of enrollment. Participants need to have confirmed diagnosis through laboratory tests and must be able to perform daily activities with minimal difficulty, corresponding to an ECOG performance status of 0 to 2. Life expectancy should be at least 12 weeks, and participants must have adequate organ and bone marrow function. Female participants of childbearing potential must use effective birth control methods and have negative pregnancy tests throughout the study. All participants must provide written informed consent before any study procedures begin.

Main exclusion criteria: The trial cannot include patients who do not have the specific types of cancer being studied or who lack the particular genetic mutations being investigated, such as changes in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D genes. Patients with breast cancer that has spread to the brain are excluded. Those outside the specified age range or who have other health conditions that would make participation unsafe cannot join the study. The trial is also not designed to include vulnerable populations.

Main focus and goals: The primary aim of this study is to assess the safety and tolerability of AZD9574 in patients with advanced cancers. Researchers want to understand how the body processes this medication and observe its initial effects on cancer progression. The trial will monitor participants through regular health checks, including blood tests and imaging scans, to track treatment response and identify any side effects. The study involves a dose escalation phase to determine the optimal amount of medication and explores how AZD9574 affects specific biomarkers that indicate how the body responds to treatment.

Investigational drugs: The main medication being tested is AZD9574, an experimental anti-cancer agent administered as an oral film-coated tablet. It works by targeting specific molecular pathways involved in cancer cell growth and survival. In some parts of the study, AZD9574 is combined with other anti-cancer agents, including temozolomide, which is given as a hard capsule taken by mouth. The combination therapy aims to enhance treatment effectiveness for specific cancer types.