A Study of RO5137382 (GC33) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | February 2012 |
| End Date: | August 2015 |
A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)
This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety
of RO5137382 (GC33) in previously treated patients with unresectable advanced or metastatic
hepatocellular carcinoma. Patients will be stratified according to the level of GPC-3
expression in tumors and randomized to receive either RO5137382 (1600 mg intravenously) or
placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study
treatment is until disease progression or unacceptable toxicity occurs.
of RO5137382 (GC33) in previously treated patients with unresectable advanced or metastatic
hepatocellular carcinoma. Patients will be stratified according to the level of GPC-3
expression in tumors and randomized to receive either RO5137382 (1600 mg intravenously) or
placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study
treatment is until disease progression or unacceptable toxicity occurs.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)
- 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)
- Not a candidate for curative treatments (e.g. resection, transplantation)
- Child-Pugh A (score of 5-6)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematologic, hepatic and renal function
- Ability to provide, for central review, a tumor tissue sample to determine the level
of GPC-3 expression by IHC
- Measurable disease by RECIST criteria
Exclusion Criteria:
- Child Pugh B or C
- Known hepatocellular carcinoma with fibro-lamellar histology
- Known brain or leptomeningeal metastases
- Active infectious diseases requiring treatment except for hepatitis B and C
- History of organ allograft including liver transplant
- Anticipated or ongoing administration of anticancer therapies other than those
administered in this study
- Anticancer treatment within 2 weeks prior to entering the study
- Patients who have not fully recovered from toxicities associated with previous HCC
loco-regional or systemic therapies
- Patients receiving interferon therapy
- Pregnant or lactating women
- Known HIV positivity or AIDS-related illness
- History of significant hypersensitivity to similar agents (monoclonal antibody,
protein-included drugs, Chinese hamster ovary products)
We found this trial at
10
sites
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