A Randomized Phase 2/3 Multi-Center Study of SM-88 in Subjects with Pancreatic Cancer Whose Disease Has Progressed or Recurred

Brief description of study

This research study is conducted in two parts. Part 1 of the study is now complete. If you choose to participate in this study, you will be participating in Part 2. The purpose of Part 2 of this study is to follow all study patients for their response to the study medication in the 2 treatment arms. In addition, you will be asked to contribute additional biometric data such as heart rate, location, etc., by wearing a FitBit or equivalent wearable device and the use an app on a cell phone or other wireless device. Part 2 has two treatment arms: Arm 1: Investigational combination known as SM-88 plus Methoxsalen, Phenytoin, and Sirolimus (collectively MPS). Methoxsalen, Phenytoin, and Sirolimus are drugs approved by the FDA for uses other than treating your cancer. You will be taking lower doses of these medicines than which is recommended for those other uses. D, L-alpha-metyrosine, also known as racemetyrosine (SM-88) is a new experimental drug that has not been approved by the FDA. Arm 2: Standard, single-drug therapy, using one of 3 FDA approved chemotherapies (intravenous gemcitabine, intravenous 5-FU, and oral capecitabine). The treatment you will receive on this arm will be determined by you and your study doctor.


Clinical Study Identifier: s18-00817
ClinicalTrials.gov Identifier: NCT03512756
Principal Investigator: Paul E. Oberstein.


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