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A Phase I Clinical Study on a New Oral Pentamidine Formulation in Hepatocellular Carcinoma

Information source: Oncozyme Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatocellular Carcinoma

Intervention: Oral Pentamidine (Drug); Placebo (Other)

Phase: Phase 1

Status: Recruiting

Sponsored by: Oncozyme Pharma Inc.

Overall contact:
Pierre Falardeau, PhD, Phone: 514-866-5325, Email: pierre.falardeau@oncozymepharma.com

Summary

The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects Undergoing Thermal Ablation

Clinical Details

Official title: A Phase I Clinical Study on the Hepatic Uptake, Pharmacokinetics, Safety and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects Undergoing Thermal Ablation

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: pharmacokinetics

Secondary outcome:

plasma Pharmacokinetics

Adverse events

markers of efficacy

Biomarker

Detailed description: This is a Phase 1, randomized, double-blind, placebo-controlled, sequential-group administration of a new oral pentamidine formulation to investigate its hepatic uptake, pharmacokinetics, safety and tolerance in subjects with hepatocellular carcinoma who undergoes thermal ablation procedure

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Pierre Falardeau, PhD, Phone: 514-866-5325, Email: pierre.falardeau@oncozymepharma.com

Dr. Kelly Burak, Calgary, Alberta T2N4Z6, Canada; Recruiting
Kelly Burak, MD
Kelly Burak, MD, Principal Investigator

Dr Morris Sherman, Toronto, Ontario M5G 2N2, Canada; Recruiting
Morris Sherman, MD
Morris Sherman, MD, Principal Investigator

Dr Marc Bilodeau, Montreal, Quebec H2X 3J4, Canada; Recruiting
Marc Bilodeau, MD
Marc Bilodeau, MD, Principal Investigator

Additional Information

Starting date: August 2014
Last updated: November 24, 2014

Page last updated: August 23, 2015

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