Clinical Trials

Inclusion Criteria:

• Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
  • Subjects with additional sites of metastasis, except known brain metastasis, are eligible;
  • Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled;
  • Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (MRI/CT scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult.
• Patients with no prior lines of therapy for the treatment of stage IV metastatic disease.
  • Patients could have had prior neoadjuvant or adjuvant chemotherapy or chemo-radiotherapy.
    • Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress > 6 months after completion of the therapy;
    • Patients who progress while on adjuvant FOLFIRINOX can enroll immediately.
• Male and female patients at least 18 years of age.
• Laboratory data as specified below:
• Hematology:
  • ANC >1500 cells/mm^3,
  • Platelet count > 100,000 cells/mm^3; and
  • Hemoglobin > 8 g/dL.
• Hepatic:
  • Direct bilirubin < 1.5 X ULN;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 x ULN;
  • For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 6.0 X ULN and direct bilirubin < 3 x ULN.
• Renal:
  • Serum creatinine WNL or creatinine clearance > 50 mL/min.
• QT intervals: QTc ≤ 470 msec for men and ≤ 490 msec for women.  (As measured by Hodges’ Equation:  QTc = QT + 1.75(rate-60) where QTc = corrected QT interval and rate = ventricular rate/min).
• Estimated life expectancy of at least 3 months.
• ECOG Performance Status 0-1.
• Ability to operate the Novo TTF-100L (P) system.
• Patients must have measurable disease on scans per RECIST 1.1.
• Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment. 

Exclusion Critera:

• Previous front-line therapy for metastatic disease.
• Patients with known brain metastasis.
• Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker.
• Patient with cardiac or abdominal pacemakers or stimulators.
• Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction.
• Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible.
• Concomitant use of drugs that have black box warning of Torsades de Pointes will also be prohibited if cannot be replaced by another drug.
• Known sensitivity to conductive hydrogels. 
• Patients who are pregnant or breastfeeding.
• Patients who lack the capacity to consent for themselves.