Study of intravenous GC33 treatment in patients with liver cancer that cannot be resected or has metastatized and that has not responded to currently available treatment(s).

• Conditions: Second-line treatment for adult patient with unresectable advanced or metastatic hepatocellular cancer.; MedDRA version: 14.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003574-84-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-02
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

1. Male or female =18 years old
2. Life expectancy of at least 12 weeks
3. ECOG Performance Status of 0 or 1
4. Histologically confirmed unresectable advanced or metastatic
hepatocellular carcinoma (without fibrolamellar subtype)
5. Prior treatment with at least 1 systemic agent, with documented
progressive disease after systemic agent(s), or documented adverse
event(s) associated with prior systemic agent(s) that resulted in
discontinuance of that(those) agent(s)
6.Not a candidate for curative treatments(e.g.resection, transplantation)
7. Child-Pugh A (score of 5-6)
8. Adequate hematologic function: Platelet count = 50x 109/L, Absolute
Neutrophil Count = 1,500/µL, Hemoglobin = 8.0 g /dL
9. Adequate hepatic function: ALT (SGPT), AST (SGOT) = 5 x ULN,
Bilirubin = 2 mg/ dL
10. Adequate renal function: Serum Creatinine = 2 x ULN or calculated
Creatinine Clearance = 60 ml/min using Cockcroft and Gault formula
11. Ability to provide, for central review, a tumor tissue sample
containing at least 5 % tumor cells to determine the level of GPC-3
expression by IHC. Determination of GPC-3 expression level is required
prior to study entry.
12. Patients must have recovered from effects of any major surgery or
significant traumatic injury at least 14 days before the first dose of study
treatment
13. Measurable disease (by RECIST 1.1) prior to the administration of
study treatment
14. Negative serum pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

1. Child-Pugh B or C
2. Known HCC with fibro-lamellar histology
3. Known brain or leptomeningeal metastases
4. Patients with a previous malignancy within the past 5 years are
excluded(patients who had curatively treated basal cell carcinoma of the
skin,early gastrointestinal cancer by endoscopic resection, and/or insitu
carcinoma of the cervix and other malignancies which were considered
cured and deemed by the PI to have no impact on the PFS and OS are
allowed after discussion with the study medical monitor)
5. Active infectious diseases requiring treatment except for hepatitis B and C
6. NCI CTCAE version 4.0 grade 3 hemorrhage within 4 weeks of starting
the study treatment
7. History of organ allograft including liver transplant
8. Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
9. Patient who have had any anticancer treatment within 2 weeks prior to entering the study
10. Patients who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies
11. Patients receiving Interferon therapy
12. Patients with baseline QTc > 470 ms, or patients with baseline
resting bradycardia <45 beats per minutes.
13. Patients who received anticoagulation or thrombolytic agents for therapeutic purposes (except for low-dose administration for catheter
clearance or for prophylactic purposes)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified