A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer

Stopped early · Phase 2/Phase 3

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT03512756

Run by

Tyme, Inc

People needed

130

Starts

2018-03-27

Expected to finish

2021-12-28

Last updated by the study team

2024-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• Part 1
• Biopsy-proven metastatic pancreatic adenocarcinoma with documented radiographic disease progression on or after one or more systemic therapies. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy. Chemotherapy given for at least 4 months as adjuvant after complete response is considered as a first line therapy.
• Part 2
• Biopsy-proven metastatic pancreatic adenocarcinoma on or after two prior lines of systemic therapy. Chemotherapy given as part of prior chemo- radiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy unless metastases develop within 6 months of completing the chemo sensitization. Chemotherapy given for at least 4 months as adjuvant after a CR to any therapy (e.g. surgery and radiation therapy) is also considered as a first line therapy. Of the two prior lines, participants should have received a gemcitabine-based regimen for a prior line and a 5-FU based regimen as a prior line of therapy. Investigational therapies as part of a prior line regimen are permitted.
• Participants Have received two (2) and not more than two (2) previous systemic regimens for the treatment of pancreatic adenocarcinoma
• Must be eligible to receive one or more of the Physician Choice options.
• Radiographically measurable disease of at least one site by CT scan (or MRI, if allergic to CT contrast media). Imaging results must be obtained within the 14-day window prior to randomization
• Must have completed any investigational cancer therapy at least 30 days prior to first dose.
• Must have completed any other cancer therapy at least 14 days prior to first dose and recovered from major side effects of prior therapies or procedures.
• ≥18 years of age.
• ECOG PS ≤2.
• Adequate organ function defined as follows (lab results must be obtained within the 7-day window prior to randomization):
• All laboratory parameters ≤ Grade 2 NCI Common Terminology Criteria for Adverse Events (CTCAE) criteria.
• In addition:
• i. Hematologic: Platelets ≥ 100 x 109 g/dL; Absolute Neutrophil Count ≥ 1.5 x 109/L (without platelet transfusion or growth factors within the 7 days prior to the screening laboratory assessment).
• ii. Hepatic: transaminase /alanine transaminase ≤ 2.5 x upper limit of normal (ULN); total or conjugated bilirubin ≤ 1.5 x ULN, alkaline phosphatase (ALP) < 2.5 x ULN.
• iii. Renal: serum creatinine ≤1.5 x ULN and creatinine clearance ≥ 60 mL/min as calculated by the Cockroft-Gault method.
• iv. Coagulation: International normalized ratio (INR) ≤ 1.2 within 28 days of starting study.
• v. Albumin: ≥ 3.0 g/dL. vi. Weight: No more than a 5% change from Screening to Randomization (must be at least 1 week apart).
• All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before baseline, with the exception of alopecia and neurotoxicity (CTCAE Grade 1 or 2 permitted).
• Able and willing to provide written informed consent to participate in this study.
• Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• Must be able to swallow whole capsules.
• Females must either be of non-reproductive potential, not breast-feeding or must have a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on Day 1.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City Of Hope — Duarte, California, United States
• Sarcoma Oncology Research Center — Santa Monica, California, United States
• Hartford Healthcare Cancer — New Britain, Connecticut, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Advent Health Florida Hospital Tampa — Tampa, Florida, United States
• June E. Nylen Cancer Center — Sioux City, Iowa, United States
• University Medical Center — New Orleans, Louisiana, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• North Shore Hematology Oncology — East Setauket, New York, United States
• NY Cancer and Blood Specialist — East Setauket, New York, United States
• NYU Langone Health — New York, New York, United States
• Central Park Hematology & Oncology — New York, New York, United States
• Weill Cornell — New York, New York, United States
• New York Cancer and Blood Specialist — The Bronx, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Texas Oncology-Baylor — Dallas, Texas, United States
• MD Anderson — Houston, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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