Clinical trial NCT02210182 (phase 1, status: completed)
Conditions: hepatocellular carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: oral pentamidine
SMILES: NC(=N)C1=CC=C(OCCCCCOC2=CC=C(C=C2)C(N)=N)C=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects

          2. 18 years of age or older

          3. Radiologically established diagnosis of hepatocellular carcinoma (HCC) with tumor
             diameter ≤ 5 cm

          4. Suitable for and scheduled to undergo thermal ablation as treatment

          5. Have a Barcelona score of 0 or A

          6. Have a Child Pugh score of A or B

          7. Legally and mentally able to give informed consent to participate in the study

          8. Signature of a dated Informed Consent Form (ICF) indicating that the subject has been
             informed of all the relevant aspects of the trial prior to enrolment

          9. Willingness and ability to comply with scheduled visits and trial procedures

        Exclusion Criteria:

          1. Presence of uncontrolled diabetes, defined as glycated hemoglobin (Hb1Ac) ≥ 8.0

          2. History of clinically significant hypoglycaemia, with fasting blood glucose < 3 mmol/L
             within 3 months prior to signature of ICF

          3. Presence of clinically significant renal impairment, defined as a creatinine clearance
             < 60 mL/min

          4. Systolic Blood Pressure < 100 mm Hg (if deemed clinically significant by the treating
             physician)

          5. Current or recent (< 2 years) history of pancreatitis

          6. International Normalised Ratio (INR) > 1.5 or presence of severe coagulation disorders
             (vg but limited to prothrombin activity < 40% or a platelet count of < 40,000 / mm3)

          7. Presence of known vascular invasion, bile duct invasion or extrahepatic metastasis

          8. Presence of portal venous thrombosis

          9. Concomitant therapy with other investigational agents or participation in another
             clinical trial within 3 months of signature of ICF

         10. Previous use of pentamidine with treatment discontinuation of less than 6 months prior
             to signature of ICF

         11. Any of the following conditions: Ongoing clinically significant cardiac dysrhythmias
             such as atrial fibrillation ; QTc interval > 450 msec for males or > 470 msec for
             females or uncontrolled intercurrent cardiac illness, e.g. unstable angina; severe
             coronary disease, ventricular arrhythmias, bradycardia < 50 bpm (unless caused by
             beta-blocker); a history of additional risk factors for torsades de pointes (e.g.,
             heart failure or family history of Long QTC Syndrome)

         12. Presence of clinically significant hypokalemia or hypomagnesemia

         13. Concurrent use of nephrotoxic drugs

         14. Concurrent use of cardiotoxic drugs

         15. Concurrent use of drugs that may be associated with pancreatitis

         16. History of allergy or hypersensitivity to pentamidine

         17. Pregnancy or breastfeeding. All female subjects of childbearing potential must have a
             negative urine pregnancy test prior to first dose of study medication.

         18. Acute or chronic severe medical or psychiatric condition, or laboratory abnormality
             that would impart, in the judgement of the investigator, excess risk associated with
             trial participation of study drug administration, or which in the judgement of the
             investigator, would make the subject inappropriate for entry into this trial