A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer
Public ClinicalTrials.gov record NCT03512756. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase 2/3 Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03512756
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Interventions
- SM-88 used with MPS (methoxsalen, phenytoin, sirolimus) Drug
- Capecitabine, Gemcitabine, and 5-FU Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2018 (Actual)
- Primary completion
- Dec 28, 2021 (Actual)
- Completion
- Dec 28, 2021 (Actual)
- Last update posted
- Nov 6, 2024
2018 – 2021
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| City Of Hope | Duarte | California | 91010 | — |
| Sarcoma Oncology Research Center | Santa Monica | California | 90403 | — |
| Hartford Healthcare Cancer | New Britain | Connecticut | 06053 | — |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | — |
| Advent Health Florida Hospital Tampa | Tampa | Florida | 33613 | — |
| June E. Nylen Cancer Center | Sioux City | Iowa | 51101 | — |
| University Medical Center | New Orleans | Louisiana | 70112 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| North Shore Hematology Oncology | East Setauket | New York | 11733 | — |
| NY Cancer and Blood Specialist | East Setauket | New York | 11733 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Central Park Hematology & Oncology | New York | New York | 10028 | — |
| Weill Cornell | New York | New York | 10065 | — |
| New York Cancer and Blood Specialist | The Bronx | New York | 10469 | — |
| The Ohio State University | Columbus | Ohio | 43221 | — |
| Texas Oncology-Baylor | Dallas | Texas | 75246 | — |
| MD Anderson | Houston | Texas | 77030 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03512756, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2024 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03512756 live on ClinicalTrials.gov.