A Randomized Phase 2/3 Multi-Center Study of SM-88 in Patients With Metastatic Pancreatic Cancer
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
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.