A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: Tyme, Inc
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Treatment Details
2Treatment groups
Experimental Treatment
Group I: Physician's ChoiceExperimental Treatment1 Intervention
Physician's Choice therapy will be administered for a total of 125 evaluable participants until unacceptable toxicity, disease progression, or any of the treatment discontinuation criteria are met.
Group II: Part 1 and Part 2 SM-88 ArmExperimental Treatment1 Intervention
(Part 1 enrollment complete) SM-88 used with MPS (methoxsalen, phenytoin and sirolimus)
(Part 2 actively enrolling) SM-88 (920 mg per day) used with MPS (methoxsalen, phenytoin and sirolimus) will be administered to 125 evaluable participants until unacceptable toxicity, disease progression, or any of the treatment discontinuation criteria are met.
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Ohio State UniversityColumbus, OH
Sarcoma Oncology Research CenterSanta Monica, CA
University Medical CenterNew Orleans, LA
Washington UniversitySaint Louis, MO
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Who is running the clinical trial?
Tyme, IncLead Sponsor