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).

Phase 1

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

• Registration Number: EUCTR2011-003574-84-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 185

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) patients who are not candidate for or progressed on loco-regional therapy
5. Prior treatment with at least 1 systemic agent, (such as Sorafenib or other experimental agents), 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86

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) within 2 weeks prior to Day 1

Study & Design

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