Hepatocellular CarcinomaPhase 2NCT03069508
Clemizole HCl for Subjects With Hepatocellular Carcinoma
A Phase 2 study testing Clemizole Hydrochloride in people with Hepatocellular Carcinoma, run by Eiger Group International, Inc. at 1 site in Turkey (Türkiye).
Trial summary
This study is a phase IIa open label pilot study of up to six months treatment with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 vs. 500 mg mg) given orally TID to subjects with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Clemizole Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2017to 31 Jan 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, at least 18 years of age.
- Subjects should have a diagnosis (histologically proven) of hepatocellular carcinoma (that is measurable on CT or MR with contrast) and are either awaiting transplantation or have an unresectable lesion for which they have not received prior experimental systemic treatments for HCC and no additional therapy is planned.
- Eastern Cooperative Oncology Group performance status of 2 or less.
- Child-Pugh (CP) score of A or B.
- Life expectancy of at least 12 weeks.
- Elevated alphafetoprotein (AFP) level .
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- Adequate hematologic (platelet count, ≥60 ; hemoglobin, ≥8.5 g per deciliter; and prothrombin time international normalized ratio, ≤2.3; or prothrombin time, ≤6 seconds above control), hepatic (albumin, ≥2.8 g per deciliter; total bilirubin, ≤3 mg per deciliter [51.3 μmol per liter]; and alanine aminotransferase and aspartate aminotransferase, ≤5 times the upper limit of the normal range), and renal (serum creatinine, ≤1.5 times the upper limit of the normal range) function.
- Electrocardiogram (ECG) showing no acute ischemia or clinically significant abnormality and a QT/QTc interval <450 milliseconds for males or <470 milliseconds for females using Bazett's correction (QTc =QT/RR0.5;ICH Guidance E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs)
- Females of childbearing potential (intact uterus and within one year since the last menstrual period) should be non-lactating and have a negative serum pregnancy test. In addition, all subjects (male and female) and their sexually active partners should agree to use one of the following acceptable birth control methods throughout the study:
- surgical sterilization (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) six month minimum
- IUD in place for at least three months
- barrier methods (condom or diaphragm) with spermicide
- surgical sterilization of the partner (vasectomy for six months)
- hormonal contraceptives for at least three months prior to the first dose of study drug
- Willing and able to comply with study procedures and provide written informed consent
Who cannot join
- Participation in a clinical trial with or use of any investigational agent within 30 days of Study Visit 1
- Patients co-infected with HIV
- Patients with screening tests positive for anti-HIV Ab
- Patients with tumors of mixed histology or fibrolamellar variant,
- Pregnant or lactating women,
- Patients requiring systemic anticancer therapy, or biologic-response modifiers
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- Medical/psychological/social problems that might affect study participation or evaluations
- Eating disorder or alcohol abuse within the past two years, excessive alcohol intake (>20 g per day for females (1.5 standard alcohol drinks) or >30 g per day for males (2.0 standard alcohol drinks) (a standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine or 1.5 oz of spirits) (1.0 fluid oz (US) = 29.57 mL) or if in the opinion of the investigator, an alcohol use pattern that will interfere with study conduct
- Drug abuse within the last six months
- Patients with absolute neutrophil count (ANC) <1500 cells/mm3;
- Abnormal TSH, T4 or T3
- History or clinical evidence of any of the following:
- variceal bleeding, difficult to treat ascites, hepatic encephalopathy, CTP score >8,
- immunologically mediated disease (e.g, rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) requiring more than intermittent non-steroidal anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids (inhaled asthma medications are allowed)
- significant or unstable cardiac disease (e.g., angina, congestive heart failure, uncontrolled hypertension, history of arrhythmia)
- chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment
- severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization
- Patients with a body mass index of >30 kg/m2
- Chronic use of concomitant drugs known to prolong the QT interval (See Appendix E)
- Concomitant use of immunosuppressive or immune modulating agents
- Patients with any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed or increase the risk to the subject of participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Open Label Pilot Study of Clemizole Hydrochloride Given Orally Thrice a Day, for Subjects With Hepatocellular Carcinoma That Are Either Awaiting Transplantation or Have an Unresectable Lesion
This study is a phase IIa open label pilot study of up to six months treatment with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 vs. 500 mg mg) given orally TID to subjects with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion.
Read the detailed description
The primary objectives of the study are to:
- Evaluate the safety and tolerability of up to six months of treatment with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg TID by mouth) in subjects diagnosed with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion.
- Evaluate the overall tumor response according to radiologic assessments of stable disease, complete response (CR), partial response (PR), or minor response (MR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST), associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
- Evaluate the pharmacokinetic (PK) activity of clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
The secondary objectives of the study are to:
- Evaluate the duration of response, time to progression, duration of stable disease (SD), and overall survival associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Clemizole Hydrochloride
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clemizole HydrochlorideDrug
Also called Clemizole
Clemizole Hydrochloride will be administered orally for up to 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 200 mg TID | Experimental | 200 mg clemizole hydrochloride will be administered orally thrice a day for 24 weeks. Receives: Drug: Clemizole Hydrochloride |
| 300 mg TID | Experimental | 300 mg clemizole hydrochloride will be administered orally thrice a day for 24 weeks. Receives: Drug: Clemizole Hydrochloride |
| 400 mg TID | Experimental | 400 mg clemizole hydrochloride will be administered orally thrice a day for 24 weeks. Receives: Drug: Clemizole Hydrochloride |
| 500 mg TID | Experimental | 500 mg clemizole hydrochloride will be administered orally thrice a day for 24 weeks. Receives: Drug: Clemizole Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Safety and tolerability of up to six months of treatment with clemizole hydrochloride thrice daily by mouth in subjects diagnosed with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion, determined by the number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Measured: Number of recorded adverse events at six months
Overall tumor response according to radiologic assessments associated with clemizole HCl.
Number of participants with stable disease, complete response (CR), partial response (PR), or minor response (MR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST), associated with clemizole HCl.
Measured: Change from baseline up to 24 weeks
AUC Pharmacokinetic (PK) assessment of clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg by mouth)
Area under the plasma concentration versus time curve (AUC) of clemizole HCl following oral administration of 200 mg vs. 300 mg vs. 400 mg vs. 500 mg.
Measured: 0-pre-dose, post dose: 15 min, 30 min, 60 min, 90 min, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours post oral administration of clemizole HCl for those subjects participating in the PK portion of this trial
Cmax Pharmacokinetic (PK) assessment of clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg by mouth)
Peak plasma concentration (Cmax) of clemizole HCl following oral administration of 200 mg vs. 300 mg vs. 400 mg vs. 500 mg.
Measured: 0-pre-dose, post dose: 15 min, 30 min, 60 min, 90 min, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours post oral administration of clemizole HCl for those subjects participating in the PK portion of this trial
Secondary outcomes (4)
Duration of response associated with clemizole hydrochloride
Duration of response associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
Measured: First administration of study drug until progressive disease in patients with objective responses up to 24 weeks.
Time to progression associated with clemizole hydrochloride
Time to progression associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
Measured: First administration of study drug until progressive disease up to 24 weeks.
Duration of stable disease associated with clemizole hydrochloride
Duration of stable disease associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
Measured: First day of receiving clemizole until progressive disease or response up to 24 weeks.
Overall survival associated with clemizole hydrochloride
Overall survival associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
Measured: First day of receiving study medication to death up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start13 Feb 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Jan 2018 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eiger Group International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cihan Yurdaydin, MD, Principal investigator, University of Ankara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069508
- Sponsor's protocol ID
- EIG-234
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Open Label Pilot Study of Clemizole Hydrochloride Given Orally Thrice a Day, for Subjects With Hepatocellular Carcinoma That Are Either Awaiting Transplantation or Have an Unresectable Lesion
- ClinicalTrials.gov ID
- NCT03069508
- Acronym / sponsor ID
- EIG-234
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Eiger Group International, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Jan 2018 (estimated)
- First posted
- 3 Mar 2017 (actual)
- 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.
This study is a phase IIa open label pilot study of up to six months treatment with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 vs. 500 mg mg) given orally TID to subjects with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion.
Detailed description
The primary objectives of the study are to:
- Evaluate the safety and tolerability of up to six months of treatment with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg TID by mouth) in subjects diagnosed with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion.
- Evaluate the overall tumor response according to radiologic assessments of stable disease, complete response (CR), partial response (PR), or minor response (MR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST), associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
- Evaluate the pharmacokinetic (PK) activity of clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
The secondary objectives of the study are to:
- Evaluate the duration of response, time to progression, duration of stable disease (SD), and overall survival associated with clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg, TID by mouth)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200 mg TID | Experimental | Drug: Clemizole Hydrochloride200 mg clemizole hydrochloride will be administered orally thrice a day for 24 weeks. |
| 300 mg TID | Experimental | Drug: Clemizole Hydrochloride300 mg clemizole hydrochloride will be administered orally thrice a day for 24 weeks. |
| 400 mg TID | Experimental | Drug: Clemizole Hydrochloride400 mg clemizole hydrochloride will be administered orally thrice a day for 24 weeks. |
| 500 mg TID | Experimental | Drug: Clemizole Hydrochloride500 mg clemizole hydrochloride will be administered orally thrice a day for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Males or females, at least 18 years of age.
- Subjects should have a diagnosis (histologically proven) of hepatocellular carcinoma (that is measurable on CT or MR with contrast) and are either awaiting transplantation or have an unresectable lesion for which they have not received prior experimental systemic treatments for HCC and no additional therapy is planned.
- Eastern Cooperative Oncology Group performance status of 2 or less.
- Child-Pugh (CP) score of A or B.
- Life expectancy of at least 12 weeks.
Key exclusion criteria (21 listed)
- Participation in a clinical trial with or use of any investigational agent within 30 days of Study Visit 1
- Patients co-infected with HIV
- Patients with screening tests positive for anti-HIV Ab
- Patients with tumors of mixed histology or fibrolamellar variant,
- Pregnant or lactating women,
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 |
|---|---|---|
| Clemizole HydrochlorideAlso: ClemizoleClemizole Hydrochloride will be administered orally for up to 24 weeks | Drug | 200 mg TID, 300 mg TID, 400 mg TID, 500 mg TID |
Primary outcome
Number of participants with adverse events
Time frame: Number of recorded adverse events at six months
Safety and tolerability of up to six months of treatment with clemizole hydrochloride thrice daily by mouth in subjects diagnosed with hepatocellular carcinoma that are either awaiting transplantation or have an unresectable lesion, determined by the number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Overall tumor response according to radiologic assessments associated with clemizole HCl.
Time frame: Change from baseline up to 24 weeks
Number of participants with stable disease, complete response (CR), partial response (PR), or minor response (MR), as defined by Response Evaluation Criteria in Solid Tumors (RECIST), associated with clemizole HCl.
AUC Pharmacokinetic (PK) assessment of clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg by mouth)
Time frame: 0-pre-dose, post dose: 15 min, 30 min, 60 min, 90 min, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours post oral administration of clemizole HCl for those subjects participating in the PK portion of this trial
Area under the plasma concentration versus time curve (AUC) of clemizole HCl following oral administration of 200 mg vs. 300 mg vs. 400 mg vs. 500 mg.
Cmax Pharmacokinetic (PK) assessment of clemizole hydrochloride (200 mg vs. 300 mg vs. 400 mg vs. 500 mg by mouth)
Time frame: 0-pre-dose, post dose: 15 min, 30 min, 60 min, 90 min, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours post oral administration of clemizole HCl for those subjects participating in the PK portion of this trial
Peak plasma concentration (Cmax) of clemizole HCl following oral administration of 200 mg vs. 300 mg vs. 400 mg vs. 500 mg.
4 secondary outcomes
Duration of response associated with clemizole hydrochloride
Time frame: First administration of study drug until progressive disease in patients with objective responses up to 24 weeks.
Time to progression associated with clemizole hydrochloride
Time frame: First administration of study drug until progressive disease up to 24 weeks.
Duration of stable disease associated with clemizole hydrochloride
Time frame: First day of receiving clemizole until progressive disease or response up to 24 weeks.
Overall survival associated with clemizole hydrochloride
Time frame: First day of receiving study medication to death up to 24 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Cihan Yurdaydin, MD principal investigator
University of Ankara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clemizole Hydrochloride in people with Hepatocellular Carcinoma, run by Eiger Group International, Inc. at 1 site in Turkey (Türkiye).
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 15 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of participants with adverse events (time frame: Number of recorded adverse events at six months). The study lists 4 primary outcomes in all. 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 3 Mar 2017.