Phase 2/3Terminated
A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer
A Randomized Phase 2/3 Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred
- Sponsor
- Tyme, Inc (Industry)
- Enrolment
- 130 enrolled
- Conditions
- Pancreatic Cancer
- Interventions
- SM-88 used with MPS (methoxsalen, phenytoin, sirolimus); Capecitabine, Gemcitabine, and 5-FU
- Ages
- adults, older adults
- Registry
- NCT03512756
Full record on ClinicalTrials.gov
From the registry
A prospective, open-label phase 2/3 trial in metastatic pancreatic cancer participants 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 participants), 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 participants in the second part will be randomized 1:1 either to the SM-88 arm (125 participants) or Physician's Choice of therapy for the Control Arm (125 participants). Participants should have previously received two lines of prior systemic therapy.
Primary outcomes
- Overall Survival (OS)
History
Results first posted
Last registry update
Primary completion
Registered
Started