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Hepatocellular CarcinomaPhase 1NCT00976170

Study of GC33 and Sorafenib in Combination in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)

A Phase 1 study testing GC33(RO5137382) and Sorafenib in people with Hepatocellular Carcinoma, run by Chugai Pharmaceutical at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial is studying the safety and best dose of GC33 and Sorafenib in combination 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
Hepatocellular Carcinoma
What is being tested?
GC33(RO5137382) and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
7 sitesin 2 countries
Study dates
Sep 2009to Sep 2014
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/Ethical Committee approved informed consent form.
  • Male or female ≥18 years old.
  • Life expectancy ≥3 months.
  • ECOG Performance Status of 0-1.
  • Histologically confirmed hepatocellular carcinoma.
  • Not a candidate for curative treatments.
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  • Child-Pugh A
  • Hematological, Biochemical and Organ Function:
  • AST (SGOT): ≤5.0 × ULN,
  • ALT (SGPT): ≤5.0 × ULN,
  • Total Bilirubin: ≤1.5mg/dL,
  • Platelets: ≥100,000/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 formalin fixed paraffin embedded block sample within 12 months prior to informed consent for HCC diagnosis
  • Undergo a biopsy to confirm HCC diagnosis
  • Measurable disease.

Who cannot join

  • Child-Pugh B or C
  • Patient who have taken Sorafenib previously.
  • Difficulty or inability to swallow pills.
  • 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.
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  • Other malignancies within the last 5 years.
  • History of transplantation (organ, bone marrow transplantation, Peripheral blood stem cell transplantation, etc.).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements..
  • Patients with known brain metastases or other central nervous system disease/disorders.
  • Uncontrolled hypertension defined as systolic blood pressure >150 mmhg or diastolic blood pressure >90 mmHg, despite optimal medical management.
  • Non-tumor related thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 3, any other hemorrhage/bleeding event ≥ CTCAE Grade 4 within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • 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(6 weeks for nitrosoureas, mitomycin, and bevacizumab; 1 week for tumor biopsy).
  • Patients who received the following treatments within 2 weeks prior to Day 1:
  • Anticoagulant or thrombolytic agents for therapeutic purposes,
  • Systemic anti-viral therapy for hepatitis C and Interferon therapy for hepatitis B,
  • Blood transfusion including all blood products
  • Known history of hypersensitivity to similar agents.
  • Patients receiving any medications or substances that are inducers of CYP3A4 are ineligible: rifampin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone.
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States5 sites

  • University of North Carolina

    Chapel Hill, North Carolina

  • University of Miami

    Miami, Florida

  • Memorial Sloan-Kettering Cancer Center

    New York, New York

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • California Pacific Medical Center

    San Francisco, California, 94115

Other trials in United States

Taiwan2 sites

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan Univercity Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 in Combination With Sorafenib (Nexavar®) in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC).

This phase I trial is studying the safety and best dose of GC33 and Sorafenib in combination 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 combination with Sorafenib in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.

Being tested
GC33(RO5137382), Sorafenib
Keywords
Advanced or metastatic HCC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GC33(RO5137382)Drug

    IV administration at 6 escalating dose levels.

  • SorafenibDrug

    Oral administration at 400mg twice daily or 400mg once daily

Study groups in NCT00976170
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: GC33(RO5137382); Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity evaluation in accordance with CTCAE v3.0

    Measured: Continuous

  2. Dose limiting toxicity and maximum tolerated dose

    Measured: Continuous

Secondary outcomes (2)

  1. RECIST criteria (version 1.0) for response evaluation by CT/MRI in target and non-target lesions of HCC

    Measured: every 2 months

  2. Repeat-dose pharmacokinetic behavior of GC33 and Sorafenib

    Measured: Continuous

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2013
  4. Study completionSep 2014

Resources

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976170
Sponsor's protocol ID
GC-002US
Status last verified
Oct 2014
First submitted
9 Sep 2009
Last updated
3 Oct 2014
Results posted
No

Publications

  • Abou-Alfa GK, Yen CJ, Hsu CH, O'Donoghue J, Beylergil V, Ruan S, Pandit-Taskar N, Gansukh B, Lyashchenko SK, Ma J, Wan P, Shao YY, Lin ZZ, Frenette C, O'Neil B, Schwartz L, Smith-Jones PM, Ohtomo T, Tanaka T, Morikawa H, Maki Y, Ohishi N, Chen YC, Agajanov T, Boisserie F, Di Laurenzio L, Lee R, Larson SM, Cheng AL, Carrasquilo JA. Phase Ib study of codrituzumab in combination with sorafenib in patients with non-curable advanced hepatocellular carcinoma (HCC). Cancer Chemother Pharmacol. 2017 Feb;79(2):421-429. doi: 10.1007/s00280-017-3241-9. Epub 2017 Jan 24.

    PubMed 28120036

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GC33(RO5137382) and Sorafenib in people with Hepatocellular Carcinoma, run by Chugai Pharmaceutical at 7 sites in 2 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 19 inclusion and 22 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 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Taiwan. 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?

Toxicity evaluation in accordance with CTCAE v3.0 (time frame: Continuous). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00976170, which also lists 1 linked publication.

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 Oct 2014.

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