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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced or Metastatic HCC

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Trial Information

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 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.


Inclusion Criteria:



- 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 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.

Exclusion Criteria:

- 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.).

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the safety and tolerability of escalating doses of GC33

Outcome Time Frame:

Continuously

Safety Issue:

Yes

Principal Investigator

Toshihiko Ohtomo

Investigator Role:

Study Chair

Investigator Affiliation:

Chugai Pharmaceutical

Authority:

United States: Food and Drug Administration

Study ID:

GC-001US

NCT ID:

NCT00746317

Start Date:

September 2008

Completion Date:

October 2012

Related Keywords:

  • Advanced or Metastatic HCC
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Methodist HospitalHouston, Texas  77030
Washington UniversitySt. Louis, Missouri  63110
Columbia University Medical CenterNew York, New York  10032
Karmanos Cancer Center at the Detroit Medical CenterDetroit, Michigan  48201
Swedish Cancer Institute at the Swedish Medical CenterSeattle, Washington  98104