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

NCT00976170 | Completed Phase 1

• 1 other identifier: GC-002US
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Advanced or metastatic HCC

Outcome Measures

Primary Outcomes (2)

• Toxicity evaluation in accordance with CTCAE v3.0

  Continuous

• Dose limiting toxicity and maximum tolerated dose

  Continuous

Secondary Outcomes (2)

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

  every 2 months

• Repeat-dose pharmacokinetic behavior of GC33 and Sorafenib

  Continuous

Study Arms (1)

1

EXPERIMENTAL

Drug: GC33(RO5137382); Drug: Sorafenib

Interventions

GC33(RO5137382) DRUG

IV administration at 6 escalating dose levels.

1

Sorafenib DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Chugai Pharmaceutical: lead
• Hoffmann-La Roche: collaborator

Study Sites (7)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Miami

Miami, Florida, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Location

University of North Carolina

Chapel Hill, North Carolina, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan Univercity Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 28120036 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

codrituzumab; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

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 9, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2014
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

US (5); TW (2)