Status:
COMPLETED
A Phase I Clinical Study on a New Oral Pentamidine Formulation in Hepatocellular Carcinoma
Lead Sponsor:
Oncozyme Pharma Inc.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 ...
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 t...
Eligibility Criteria
Inclusion
- Male or female subjects
- 18 years of age or older
- Radiologically established diagnosis of hepatocellular carcinoma (HCC) with tumor diameter ≤ 5 cm
- Suitable for and scheduled to undergo thermal ablation as treatment
- Have a Barcelona score of 0 or A
- Have a Child Pugh score of A or B
- Legally and mentally able to give informed consent to participate in the study
- 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
- Willingness and ability to comply with scheduled visits and trial procedures
Exclusion
- Presence of uncontrolled diabetes, defined as glycated hemoglobin (Hb1Ac) ≥ 8.0
- History of clinically significant hypoglycaemia, with fasting blood glucose \< 3 mmol/L within 3 months prior to signature of ICF
- Presence of clinically significant renal impairment, defined as a creatinine clearance \< 60 mL/min
- Systolic Blood Pressure \< 100 mm Hg (if deemed clinically significant by the treating physician)
- Current or recent (\< 2 years) history of pancreatitis
- 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)
- Presence of known vascular invasion, bile duct invasion or extrahepatic metastasis
- Presence of portal venous thrombosis
- Concomitant therapy with other investigational agents or participation in another clinical trial within 3 months of signature of ICF
- Previous use of pentamidine with treatment discontinuation of less than 6 months prior to signature of ICF
- 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)
- Presence of clinically significant hypokalemia or hypomagnesemia
- Concurrent use of nephrotoxic drugs
- Concurrent use of cardiotoxic drugs
- Concurrent use of drugs that may be associated with pancreatitis
- History of allergy or hypersensitivity to pentamidine
- Pregnancy or breastfeeding. All female subjects of childbearing potential must have a negative urine pregnancy test prior to first dose of study medication.
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02210182
Start Date
August 1 2014
End Date
December 1 2015
Last Update
March 14 2016
Active Locations (3)
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1
Dr. Kelly Burak
Calgary, Alberta, Canada, T2N4Z6
2
Dr Morris Sherman
Toronto, Ontario, Canada, M5G 2N2
3
Dr Marc Bilodeau
Montreal, Quebec, Canada, H2X 3J4