Advanced or Metastatic HCCPhase 1NCT00746317
A Phase I Study of GC33 in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)
A Phase 1 study testing GC33 in people with Advanced or Metastatic HCC, run by Chugai Pharmaceutical at 9 sites in United States.
Trial summary
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic HCC
- What is being tested?
- GC33
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2008to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form
- Male or female ≥ 18 years old.
- Life expectancy ≥ 3 months.
- ECOG Performance Status of 0-1.
- Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).
- Not a candidate for curative treatments.
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- Child-Pugh A or B.
- Hematological, Biochemical and Organ Function:
- AST (SGOT): ≤ 5.0 × ULN
- ALT (SGPT): ≤ 5.0 × ULN
- Total Bilirubin: ≤ 3.0 × ULN
- Platelets: ≥ 50,000/μL
- Absolute Neutrophil Count: ≥ 1,500/μL
- Serum creatinine: ≤ 2.0 × ULN
- PT-INR: ≤ 2.0,
- Ability to provide a tumor tissue sample either by:
- a sample obtained within 3 months prior to informed consent for HCC diagnosis. Resection samples are not acceptable.
- undergo a biopsy to confirm HCC diagnosis
- At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria.
- (Extension Phase)
- Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form.
- Male or female ≥ 18 years old.
- Life expectancy ≥ 3 months.
- ECOG Performance Status of 0-1.
- Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).
- Not a candidate for curative treatments.
- Child-Pugh A.
- Hematological, Biochemical and Organ Function:
- AST (SGOT): ≤ 5.0 × ULN
- ALT (SGPT): ≤ 5.0 × ULN
- Total Bilirubin: ≤ 3.0 × ULN
- Platelets: ≥ 50,000/μL
- Absolute Neutrophil Count: ≥ 1,500/μL
- Serum creatinine: ≤ 2.0 × ULN
- PT-INR: ≤ 2.0
- IHC confirmed GPC3-positive HCC tumor tissue. Tumor tissue sample may be provided by:
- A formalin fixed paraffin embedded block sample within 12 months prior to informed consent for HCC diagnosis;
- Unstained slides obtained within 3 months prior to informed consent for HCC diagnosis;
- Undergo biopsy to confirm GPC3-positive HCC.
- Resection samples are not acceptable.
- At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria.
Who cannot join
- Child-Pugh C.
- Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
- Patients known to be positive for Human immunodeficiency virus infection.
- Active infectious diseases requiring treatment except for hepatitis B and C.
- Other malignancies within the last 5 years.
- History of transplantation (organ, bone marrow transplantation,peripheral blood stem cell transplantation, etc.).
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- Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug.
- Patients with brain metastases, other central nervous system or other psychiatric disease.
- Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1.
- Patients who received the following treatments within 2 weeks prior to Day1:
- Anticoagulant or thrombolytic agents for therapeutic purposes.
- Systemic anti-viral therapy for hepatitis C/cirrhosis.
- Blood transfusion
- History of hypersensitivity to similar agents.
- Patient is unable to comply with the requirements of the protocol and/or follow-up procedures.
- (Extension Phase)
- Child-Pugh B or C.
- Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
- Patients known to be positive for Human immunodeficiency virus infection.
- Active infectious diseases requiring treatment except for hepatitis B and C.
- Other malignancies within the last 5 years.
- History of transplantation (organ, bone marrow transplantation, Peripheral blood stem cell transplantation, etc.).
- Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug.
- Patients with brain metastases, other central nervous system or other psychiatric disease.
- Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1.
- Patients who received the following treatments within 2 weeks prior to Day 1:
- Anticoagulations or thrombolytic agents for therapeutic purposes.
- Systemic anti-viral therapy for hepatitis C/cirrhosis.
- Blood transfusion
- History of hypersensitivity to similar agents.
- Patient is unable to comply with the requirements of the protocol and/or follow-up procedures.
- IHC confirmed GPC3-negative HCC tumor tissue.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Karmanos Cancer Center at the Detroit Medical Center
Detroit, Michigan, 48201
Methodist Hospital
Houston, Texas, 77030
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Columbia University Medical Center
New York, New York, 10032
Swedish Cancer Institute at the Swedish Medical Center
Seattle, Washington, 98104
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.
Read the detailed description
This is a Phase I open-label dose escalation study of GC33 in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary assessment of anti-tumor activity. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.
- Conditions
- Advanced or Metastatic HCC
- Being tested
- GC33
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC33Drug
IV administration at 4 escalating dose levels.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: GC33 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and tolerability of escalating doses of GC33
Measured: Continuously
Secondary outcomes (2)
Characterize the pharmacokinetics of GC33
Measured: Continuously
Perform a preliminary assessment of anti-tumor activity of GC33
Measured: Continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2010
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic HCCStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshihiko Ohtomo, Study chair, Chugai Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746317
- Sponsor's protocol ID
- GC-001US
- Status last verified
- Oct 2012
- First submitted
- 1 Sep 2008
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00746317
- Acronym / sponsor ID
- GC-001US
- Conditions
- Advanced or Metastatic HCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Sep 2008 (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.
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.
Detailed description
This is a Phase I open-label dose escalation study of GC33 in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary assessment of anti-tumor activity. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GC33 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form
- Male or female ≥ 18 years old.
- Life expectancy ≥ 3 months.
- ECOG Performance Status of 0-1.
- Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).
Key exclusion criteria (32 listed)
- Child-Pugh C.
- Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
- Patients known to be positive for Human immunodeficiency virus infection.
- Active infectious diseases requiring treatment except for hepatitis B and C.
- Other malignancies within the last 5 years.
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 |
|---|---|---|
| GC33IV administration at 4 escalating dose levels. | Drug | 1 |
Primary outcome
Determine the safety and tolerability of escalating doses of GC33
Time frame: Continuously
2 secondary outcomes
Characterize the pharmacokinetics of GC33
Time frame: Continuously
Perform a preliminary assessment of anti-tumor activity of GC33
Time frame: Continuously
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 17 Oct 2012.
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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.
Toshihiko Ohtomo study chair
Chugai Pharmaceutical
9 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 GC33 in people with Advanced or Metastatic HCC, run by Chugai Pharmaceutical at 9 sites in United States.
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 41 inclusion and 32 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 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 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?
Determine the safety and tolerability of escalating doses of GC33 (time frame: Continuously). 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 17 Oct 2012.