TAS-120-302 Study Information Sheet

TAS-120-302 Study Information Sheet

What is the Aim of the Project?

This is a clinical research trial of TAS-102, which is the drug under investigation for the treatment of metastatic stomach cancer. This means that TAS-102 has not been approved for use in the country of your residence and/or for use in subjects with your particular diagnosis, except in a clinical research trial. TAS-102, under the brand name Lonsurf® (trifluridine and tipiracil), was approved in the U.S. on 22 September 2015 for the treatment of patients with metastatic colorectal cancer.

The purpose of this trial is to compare the effects, good and/or bad, of TAS-102 and best supportive care with Placebo (an inactive drug) and best supportive care on you and your advanced stomach cancer to find out the effects on how long you may live, how much time may pass without your stomach cancer getting worse, and safety.

What Type of Participants are being Sought?

The trial will enroll male and female patients who are 18 years or older with metastatic stomach cancer, specifically adenocarcinoma including adenocarcinoma of the gastroesophageal (GE) junction, who have received at least 2 prior regimens for advanced disease and the treatment did not work or the patient was or unable to tolerate their last prior therapy.

What will Participants be Asked to Do?

To see if you qualify for the study, you will be asked to provide a medical history and cancer history, complete a questionnaire about your health and undergo a physical exam, CT scan and laboratory tests. If you qualify, you will be asked to take TAS-102 or a placebo by mouth five days a week for 2 weeks during each 4-week treatment cycle. The testing you underwent before the study will be repeated periodically to monitor your health and to measure how your stomach cancer responds to TAS-102 or placebo. You will also be asked if you have any side effects.

What Data or Information will be Collected and What Use will be Made of it?

Medical history, cancer history, health status questionnaire, physical exam, CT scan data, laboratory tests, prior cancer treatments, prior and current medications, tumor assessments and survival status, date of birth, address and other details will be collected. The data will be used for the purposes of analysis, for submission to their Regulatory Authorities worldwide and possibly for publication. The data protection laws in countries vary, however all the parties involved in this process have a duty to protect your identity and use the data for legitimate healthcare purposes only.

Can Participants Change their Mind and Withdraw from the Project?

You can decide to stop at any time and for any reason; this is referred to as withdrawing your consent. Your decision to withdraw consent is solely up to you.

What if Participants have any Questions?

For further information and to locate the study site closest to your home, please consult the clinical trial posting on the clinicaltrials.gov web site (NCT02500043): https://www.clinicaltrials.gov/ct2/show/NCT02500043?term=102-302&rank=1