NCT00746317

Brief Summary

This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 17, 2012

Status Verified

October 1, 2012

Enrollment Period

2.1 years

First QC Date

September 1, 2008

Last Update Submit

October 15, 2012

Conditions

Advanced or Metastatic HCC

Outcome Measures

Primary Outcomes (1)

  • Determine the safety and tolerability of escalating doses of GC33

    Continuously

Secondary Outcomes (2)

  • Characterize the pharmacokinetics of GC33

    Continuously

  • Perform a preliminary assessment of anti-tumor activity of GC33

    Continuously

Study Arms (1)

1

EXPERIMENTAL
Drug: GC33

Interventions

GC33DRUG

IV administration at 4 escalating dose levels.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • +26 more criteria

You may not qualify if:

  • 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.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Karmanos Cancer Center at the Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute at the Swedish Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

codrituzumab

Study Officials

  • Toshihiko Ohtomo

    Chugai Pharmaceutical

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 3, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2012

Last Updated

October 17, 2012

Record last verified: 2012-10

Locations

US(9)