Evaluation of AZD2014 and Anastrozole in Metastatic Hormone Receptor-Positive Endometrial Adenocarcinoma: A Phase I/II Multicentric, Randomized, Open-Label Study

The primary objective of the study is to evaluate the efficacy of **AZD2014**, a dual mTORC1/mTORC2 inhibitor, in combination with anastrozole compared to anastrozole alone in the treatment of metastatic hormone receptor-positive endometrial adenocarcinoma. This investigation is clinically relevant as it aims to determine whether the addition of AZD2014 can enhance therapeutic outcomes in patients with this specific type of advanced and metastatic cancer, potentially offering a more effective treatment option.

The clinical trial involves a study population consisting exclusively of **female** participants, with an age range that includes both adults and older adults. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. The study focuses on individuals with **advanced and metastatic** conditions. The selection criteria for the trial population, as well as any specific lifestyle considerations such as diet or physical activity, have not been disclosed. Key inclusion or exclusion criteria are not specified in the available data.

The clinical trial is designed to evaluate the efficacy and safety of a dual **mTORC1/mTORC2 inhibitor** in combination with anastrozole compared to anastrozole alone in patients with metastatic hormone receptor-positive endometrial adenocarcinoma. This is a multicentric, randomized, non-comparative, open-label Phase I/II trial. The trial commenced on February 15, 2016, and is estimated to conclude on October 14, 2026, providing a comprehensive evaluation over a decade-long period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of the treatment arms. The trial will include regular follow-up visits to monitor the participants' response to treatment and any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the completion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement will vary depending on individual response to treatment and the progression of the disease. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial's design ensures that data collected will contribute to understanding the potential benefits and risks associated with the investigational treatment, thereby informing future therapeutic strategies for advanced and metastatic endometrial adenocarcinoma.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial's efficacy assessment details are not explicitly provided in the source data. Therefore, specific parameters or endpoints, methods, schedules, and tools for evaluating efficacy are not available for description. The trial is categorized under phase 9, with an estimated recruitment start date of February 15, 2016, and an estimated end date of October 14, 2026. Further information regarding the efficacy assessment is not included in the provided data.