Comparative Study of Onivyde from Two Production Sites in Adults with Metastatic Pancreatic Adenocarcinoma

The primary objective of this study is to compare the efficacy and safety of **Onivyde** manufactured at two different production sites in adult participants with **Metastatic Pancreatic Adenocarcinoma**. This comparison is clinically relevant as it aims to ensure consistent therapeutic outcomes and safety profiles, regardless of the manufacturing location, which is crucial for maintaining treatment standards and patient safety in this aggressive cancer type.

The clinical trial involves a total of **2 participants** diagnosed with **Metastatic Pancreatic Adenocarcinoma**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The selection process and health status of the participants beyond their diagnosis are not detailed in the available data.

The clinical trial is designed to evaluate the efficacy and safety of **Onivyde** produced at two different manufacturing sites in adult participants diagnosed with **Metastatic Pancreatic Adenocarcinoma**. This study is structured as a Phase 2, randomized, double-blind, controlled trial. The trial is expected to commence recruitment on May 30, 2022, and conclude by March 3, 2025. Participants will be randomly assigned to receive Onivyde from one of the two production sites, ensuring that neither the participants nor the investigators are aware of the assignment, thus maintaining the double-blind nature of the study.

The trial will include several key visits: an initial screening visit, regular follow-up visits, and a final end-of-study visit. The screening visit will determine participant eligibility based on predefined inclusion and exclusion criteria. Follow-up visits will occur at regular intervals to monitor the participants' health status, treatment adherence, and any adverse events. The end-of-study visit will assess the overall outcomes and gather final data for analysis. The expected duration of participant involvement in the study is approximately 34 months, from the initial screening to the end-of-study visit.

Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with the study protocol, or if the investigator deems it in the participant's best interest. The study aims to provide valuable insights into the comparative effectiveness of Onivyde from different production sites, potentially influencing future manufacturing and treatment strategies for **Metastatic Pancreatic 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 of the experimental medication 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 both experimental and non-experimental treatments is not available in the provided data.

The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on May 30, 2022, with an estimated end date of March 3, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will follow a structured protocol to ensure the reliability and validity of the efficacy assessments, adhering to the standards expected in clinical research. The trial's focus on efficacy is integral to determining the potential therapeutic benefits of the investigational product under study.