Hepatocellular CarcinomaPhase 1/2NCT00073736
Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma
A Phase 1/2 study testing MB07133 300mg/m2/day, MB07133 600 mg/m2/day and MB07133 1200 mg/m2/day in people with Hepatocellular Carcinoma, run by Ligand Pharmaceuticals at 4 sites in 3 countries.
Trial summary
Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted specifically to the liver. 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?
- MB07133 300mg/m2/day, MB07133 600 mg/m2/day and MB07133 1200 mg/m2/day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2003to Jul 2007
- Phase
- Phase 1/2
- 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
- Patients with a diagnosis of local unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. "Local" is defined as disease either restricted to the liver or contiguous with the liver and no identifiable extrahepatic disease.
- Patients with Child-Pugh Class A liver function. For purposes of this trial, an eligible patient must not have Encephalopathy or Ascites and the total Child-Pugh score cannot be greater than 6 at baseline
- Males or females 18 years of age or older
- Ability to provide written informed consent before initiation of any study-related procedures and ability, in the opinion of the Principal Investigator, to comply with all the requirements of the study
- Male and female subjects who are surgically sterile, who remain abstinent, or who agree to practice double barrier forms of birth control from screening through 30 days (females) and 90 days (males), from the last dose of study medication
Who cannot join
- History of or presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, GI, pulmonary, immunological (with the exception of the presence of hepatitis B virus [HBV], HCV hepatitis, or cirrhosis), endocrine, or central nervous system disorders
- Patient has a history of cancer other than hepatocellular (excluding resected basal cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for 5 years or more).
- Patients with distant metastasis or extrahepatic disease
- An Eastern Cooperative Oncology Group (ECOG) performance status score of greater than or equal to 2
- Current encephalopathy or current treatment for encephalopathy
- History of drug or alcohol abuse within 6 months before screening
Show all 21Show fewer
- History of, or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent
- A documented variceal hemorrhage within 4 months of screening
- Neutrophil count less than or equal to 1,500/mm3, platelet count less than or equal to 100,000/mm3, hemoglobin less than or equal to 8.5 g/dL, or a Prothrombin Time (INR) greater than 1.3 (vitamin K supplementation allowed)
- Serum creatinine greater than 1.1 times the upper limit of normal
- History of human immunodeficiency virus or acquired immune deficiency syndrome
- Use of an investigational drug or product or participation in a drug study within 30 days before dosing
- Liver function defined as: serum bilirubin greater than 1.5 times the upper limit of normal or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, or serum albumin less than 3.2 g/dL
- History of gout or abnormal uric acid metabolism
- The clinical presence of ascites
- Treatment of HCC within 30 days of screening by chemotherapy or treatment of the target lesion(s) by chemoembolization, PEI, or surgery
- Radiofrequency ("RF") ablation of the target lesion(s) within 60 days of screening
- Subjects with a life expectancy of less than 12 weeks
- Subjects having received an organ transplant
- Subjects currently receiving coumadin or heparin
- Pregnant or nursing women
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Taiwan2 sites
Tri-Services General Hospital
Taipei, Nei Hu District, 114
Chang-Gung Memorial Hospital
Taipei, Taoyuan County, 333
United States1 site
University of California at Irvine
Orange, California, 92868
Hong Kong1 site
Prince of Wales Hospital - Comprehensive Cancer Trial Unit
Shatin, New Territories
About this study
Official title: A Phase 1/2 Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MB07133 in Subjects With Unresectable Hepatocellular Carcinoma and Child-Pugh Class A Liver Function
Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for this study is to determine the safety and tolerability of MB07133.
Read the detailed description
To determine the maximum tolerated dose of MB07133 when administered as a 7-day continuous i.v. To characterize the safety profile and the pharmacokinetics of MB07133 and metabolites during and after continuous infusion. To determine the effect of MB07133 on hepatocellular carcinoma (HCC) tumor size.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- MB07133 300mg/m2/day, MB07133 600 mg/m2/day, MB07133 1200 mg/m2/day, MB07133 1800 mg/m2/day, MB07133 2400 mg/m2/day
- Keywords
- Hepatocellular, Carcinoma, Liver, Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB07133 300mg/m2/dayDrug
7-day continuous infusion in 28-day cycles
MB07133 600 mg/m2/dayDrug
7-day continuous infusion in 28-day cycles
MB07133 1200 mg/m2/dayDrug
7-day continuous infusion in 28-day cycles
MB07133 1800 mg/m2/dayDrug
7-day continuous infusion in 28-day cycles
MB07133 2400 mg/m2/dayDrug
7-day continuous infusion in 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| MB07133 Dose Level 1 | Experimental | 7-day continuous infusion in 28-day cycles Receives: Drug: MB07133 300mg/m2/day |
| MB07133 Dose Level 2 | Experimental | 7-day continuous infusion in 28-day cycles Receives: Drug: MB07133 600 mg/m2/day |
| MB07133 Dose Level 3 | Experimental | 7-day continuous infusion in 28-day cycles Receives: Drug: MB07133 1200 mg/m2/day |
| MB07133 Dose Level 4 | Experimental | 7-day continuous infusion in 28-day cycles Receives: Drug: MB07133 1800 mg/m2/day |
| MB07133 Dose Level 5 | Experimental | 7-day continuous infusion in 28-day cycles Receives: Drug: MB07133 2400 mg/m2/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133
Measured: 7-day continuous infusion every 28-days as tolerated
Secondary outcomes (1)
Determine effect of MB07133 on tumor size
To determine the effect on HCC tumor size by using CT scanning, alpha-fetoprotein (AFP) concentration, and performance status.
Measured: 28 day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2003 (estimated)
- Study startSep 2003
- Primary completionJul 2007
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Isabela Niculae, MPH, Study director, Metabasis Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073736
- Sponsor's protocol ID
- HCC-101
- Status last verified
- Aug 2011
- First submitted
- 3 Dec 2003
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MB07133 in Subjects With Unresectable Hepatocellular Carcinoma and Child-Pugh Class A Liver Function
- ClinicalTrials.gov ID
- NCT00073736
- Acronym / sponsor ID
- HCC-101
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular, Carcinoma, Liver, Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Jul 2007 (actual)
- First posted
- 5 Dec 2003 (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.
Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. MB07133 is being developed for the treatment of inoperable HCC, using a platform technology known as HepDirectTM, which enables drugs to be targeted specifically to the liver. The objective for this study is to determine the safety and tolerability of MB07133.
Detailed description
To determine the maximum tolerated dose of MB07133 when administered as a 7-day continuous i.v. To characterize the safety profile and the pharmacokinetics of MB07133 and metabolites during and after continuous infusion. To determine the effect of MB07133 on hepatocellular carcinoma (HCC) tumor size.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MB07133 Dose Level 1 | Experimental | Drug: MB07133 300mg/m2/day7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 2 | Experimental | Drug: MB07133 600 mg/m2/day7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 3 | Experimental | Drug: MB07133 1200 mg/m2/day7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 4 | Experimental | Drug: MB07133 1800 mg/m2/day7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 5 | Experimental | Drug: MB07133 2400 mg/m2/day7-day continuous infusion in 28-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a diagnosis of local unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. "Local" is defined as disease either restricted to the liver or contiguous with the liver and no identifiable extrahepatic disease.
- Patients with Child-Pugh Class A liver function. For purposes of this trial, an eligible patient must not have Encephalopathy or Ascites and the total Child-Pugh score cannot be greater than 6 at baseline
- Males or females 18 years of age or older
- Ability to provide written informed consent before initiation of any study-related procedures and ability, in the opinion of the Principal Investigator, to comply with all the requirements of the study
- Male and female subjects who are surgically sterile, who remain abstinent, or who agree to practice double barrier forms of birth control from screening through 30 days (females) and 90 days (males), from the last dose of study medication
Key exclusion criteria (21 listed)
- History of or presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, GI, pulmonary, immunological (with the exception of the presence of hepatitis B virus [HBV], HCV hepatitis, or cirrhosis), endocrine, or central nervous system disorders
- Patient has a history of cancer other than hepatocellular (excluding resected basal cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for 5 years or more).
- Patients with distant metastasis or extrahepatic disease
- An Eastern Cooperative Oncology Group (ECOG) performance status score of greater than or equal to 2
- Current encephalopathy or current treatment for encephalopathy
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 |
|---|---|---|
| MB07133 300mg/m2/day7-day continuous infusion in 28-day cycles | Drug | MB07133 Dose Level 1 |
| MB07133 600 mg/m2/day7-day continuous infusion in 28-day cycles | Drug | MB07133 Dose Level 2 |
| MB07133 1200 mg/m2/day7-day continuous infusion in 28-day cycles | Drug | MB07133 Dose Level 3 |
| MB07133 1800 mg/m2/day7-day continuous infusion in 28-day cycles | Drug | MB07133 Dose Level 4 |
| MB07133 2400 mg/m2/day7-day continuous infusion in 28-day cycles | Drug | MB07133 Dose Level 5 |
Primary outcome
Safety and tolerability
Time frame: 7-day continuous infusion every 28-days as tolerated
To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133
1 secondary outcome
Determine effect of MB07133 on tumor size
Time frame: 28 day cycles
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 12 Aug 2011.
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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.
Isabela Niculae, MPH study director
Metabasis Therapeutics, Inc.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MB07133 300mg/m2/day, MB07133 600 mg/m2/day and MB07133 1200 mg/m2/day in people with Hepatocellular Carcinoma, run by Ligand Pharmaceuticals at 4 sites in 3 countries.
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 5 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: finished, as of the sponsor's last update on 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan, United States, Hong Kong. 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 combined 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.
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?
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?
Safety and tolerability (time frame: 7-day continuous infusion every 28-days as tolerated). 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 12 Aug 2011.