Hepatocellular CarcinomaPhase 1NCT02210182
A Phase I Clinical Study on a New Oral Pentamidine Formulation in Hepatocellular Carcinoma
A Phase 1 study testing Oral Pentamidine in people with Hepatocellular Carcinoma, run by Oncozyme Pharma Inc. at 3 sites in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Oral Pentamidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Dr. Kelly Burak
Calgary, Alberta, T2N4Z6
Dr Marc Bilodeau
Montreal, Quebec, H2X 3J4
Dr Morris Sherman
Toronto, Ontario, M5G 2N2
About this study
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
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
Read the 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
- Being tested
- Oral Pentamidine, Placebo
- Keywords
- Hepatocellular carcinoma, Oral Pentamidine, Endo-exonuclease
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral PentamidineDrug
Also called VLX103
Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days
PlaceboOther
Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Oral pentamidine | Experimental | Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days Receives: Drug: Oral Pentamidine |
| Placebo | Placebo comparator | Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics
Liver concentration of pentamidine in hepatocellular carcinoma tumor and surrounding tissue after oral administration for 3 days at different doses, measured in liver biopsies obtained during thermal ablation procedure
Measured: 3 days
Secondary outcomes (4)
plasma Pharmacokinetics
Plasma concentration of pentamidine after oral administration for 3 days at different doses
Measured: 3 days
Adverse events
Safety as assessed by adverse events (AE), vital signs and laboratory parameters
Measured: 3 days
markers of efficacy
The levels of Plasma pharmacodynamic markers of efficacy: ALT and AST
Measured: 3 days
Biomarker
Tissue biomarker of mechanism of action: Endo-exonuclease
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncozyme Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Colin, B.Pharm, PhD, Study director, Verlyx Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210182
- Sponsor's protocol ID
- OCZ103-300-1401
- Status last verified
- Mar 2016
- First submitted
- 4 Aug 2014
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02210182
- Acronym / sponsor ID
- OCZ103-300-1401
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Oral Pentamidine, Endo-exonuclease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Oncozyme Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral pentamidine | Experimental | Drug: Oral PentamidineOral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral PentamidineAlso: VLX103Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days | Drug | Oral pentamidine |
| PlaceboPlacebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days | Other | Placebo |
Primary outcome
pharmacokinetics
Time frame: 3 days
Liver concentration of pentamidine in hepatocellular carcinoma tumor and surrounding tissue after oral administration for 3 days at different doses, measured in liver biopsies obtained during thermal ablation procedure
4 secondary outcomes
plasma Pharmacokinetics
Time frame: 3 days
Adverse events
Time frame: 3 days
markers of efficacy
Time frame: 3 days
Biomarker
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Colin, B.Pharm, PhD study director
Verlyx Pharma Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral Pentamidine in people with Hepatocellular Carcinoma, run by Oncozyme Pharma Inc. at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetics (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.