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

NCT ID: NCT02210182

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-12-31

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 Ablation

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oral pentamidine

Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days

Group Type: EXPERIMENTAL

Oral Pentamidine

Intervention Type: DRUG

Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days

Placebo

Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days

Interventions

Oral Pentamidine

Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days

Intervention Type: DRUG

Placebo

Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days

Intervention Type: OTHER

Other Intervention Names

VLX103

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncozyme Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Colin, B.Pharm, PhD

Role: STUDY_DIRECTOR

Verlyx Pharma Inc

Locations

Dr. Kelly Burak

Calgary, Alberta, Canada

Dr Morris Sherman

Toronto, Ontario, Canada

Dr Marc Bilodeau

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

OCZ103-300-1401

Identifier Type: -

Identifier Source: org_study_id