Clinical trialPhase 2 / Phase 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
- Outcome
- Stopped earlySponsor's decision (Business decision)
- Phase
- Phase 2 / Phase 3
- Status
- Terminated
- Study type
- Interventional
- Start
- 27 March 2018
- Expected end
- 28 December 2021
- Enrollment
- 130 participants
- Sites
- 20
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- Industry
- Results posted
- 2024-11-06
- Last update
- 6 November 2024
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
Please refer to Inclusion/Exclusion Criteria and Summary
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Up to 12 months]. Median, Weeks (95% Confidence Interval). Part 1: SM-88 460 mg (n=20): 21.3 (9.7 to 35.0); Part 1: SM-88 920 mg (n=17): 15.7 (11.1 to 24.7); Part 2: SM-88 920 mg (n=33): 14.0 (11.1 to 19.4); Part 2: Physician's Choice (n=27): 24.1 (13.7 to 31.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [Up to 12 months]. Median, Weeks (95% Confidence Interval). Part 1: SM-88 460 mg (n=25): 8.0 (7.1 to 8.6); Part 1: SM-88 920 mg (n=24): 8.0 (5.6 to 11.1); Part 2: SM-88 920 mg (n=41): 7.7 (5.6 to 8.0); Part 2: Physician's Choice (n=40): 8.9 (6.0 to 12.7).