Clinical Trials Using Antineoplastic Agent Combination SM-88
Clinical trials are research studies that involve people. The clinical trials on this list are studying Antineoplastic Agent Combination SM-88. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
A Randomized Phase 2 / 3 Multi-Center Study of SM-88 in Patients With Metastatic Pancreatic Cancer
A prospective, open-label phase 2 / 3 trial in metastatic pancreatic cancer subjects who have failed two lines of prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. (Part 1 enrollment complete) In the initial stage of the trial (36 subjects), two dose levels of SM-88's metyrosine-derivative was evaluated. (Part 2 actively enrolling) The second part will consist of a subsequent expansion of the trial to further assess safety and efficacy of SM-88 used with MPS containing the selected SM-88 RP2D from Part 1. A total of 250 subjects in the second part will be randomized 1:1 either to the SM-88 arm (125 subjects) or Physician's Choice of therapy for the Control Arm (125 subjects). Subjects should have previously received two lines of prior systemic therapy.
Location: 7 locations
A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
Precision Promise is a multi-center, seamless Phase 2 / 3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. Primary Objectives - To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in 1st and / or 2nd line metastatic pancreatic cancer patients and determine which, if any, patients benefit from each investigational arm. Secondary Objectives - To determine short and long-term safety signals of each investigational arm in pancreatic cancer patients vs. SOC. - To determine progression-free survival (PFS) for each investigational arm vs. SOC. - Rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first). - Rate of clinical benefit; duration of clinical benefit.
Location: 6 locations