TYME-88-Panc Cancer Pivotal Study seeking patients with metastatic pancreatic cancer to participate in a pivotal trial.
Approximately 57,600 Americans will be diagnosed with pancreatic cancer, which is projected to be the 2nd leading cause of cancer-related death in the United States in 2020. Pancreatic cancer begins in the tissues of your pancreas – an organ in your abdomen that lies behind the lower part of your stomach. Your pancreas releases enzymes that aid digestion and hormones that help manage your blood sugar. It spreads rapidly to nearby organs and is seldom detected in its early stages.
Pancreatic cancer may cause only vague symptoms, but if you are experiencing one or more of the below unexplained symptoms that are abnormal and persistent, please see your doctor and reference pancreatic cancer.
Clinical trials are research studies that investigate new treatments or new combinations of treatments. Pancreatic cancer clinical trials are necessary to determine whether new treatments developed in the laboratory are beneficial to people living with pancreatic cancer. The Food and Drug Administration (FDA) reviews and analyzes data from successful clinical trials to determine whether an experimental treatment should be approved for a specific disease or disorder, such as pancreatic cancer.
The study medicine is an investigational cancer metabolism-based compound and you may or may not achieve a clinical benefit. By participating in the TYME-88-Panc Cancer Pivotal Study, you may:
The TYME-88-Panc Pivotal Trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. Qualified individuals will receive study medication for as long as they do not progress, with additional quarterly follow-ups as needed.
TYME is an emerging biotechnology company developing next-generation Cancer Metabolism-Based Therapies (CMBTs™) for patients with advanced cancers.
An investigational medication has been tested in the laboratory and the U.S. Food and Drug Administration (FDA) is allowing it to be tested in people. It is not approved for sale by the FDA or other government agencies. A clinical trial tests how well an investigational medication works and whether it is safe to use for a specific disease or disorder.
A clinical trial has a structured set of clinic visits, tests, and drug dosing schedule the patient must follow. Information about how you feel and how you are reacting to the study treatment is collected.
Protecting the health and safety of people who take part in clinical trials is the highest priority for clinical researchers throughout the entire study process. All clinical trials follow strict federal guidelines on how volunteers must be treated.
As a result of today’s challenges with COVID-19, and based on the Principal Investigators guidance, eligible patients may be able to take oral SM-88 at home as well as interact with the clinical trial physician through telemedicine remotely. This way we keep all participants in the TYME-88-Panc trial compliant and safe when it comes to COVID-19 guidelines and best practices.
You have the right to leave a clinical trial at any time, for any reason. If you decide to leave a trial, talk to your doctor first. You will want to know how leaving the trial might affect your health and what other treatment options may be available.