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Also known as GC33(RO5137382), RO5137382
GC33 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| GC33 (RO5137382) | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | iv Days 1 and 8, and every 2 weeks thereafter |
| GC33 | DRUG | 1600 mg iv Day 1 and 8, and every 2 weeks thereafter |
| GC33(RO5137382) | DRUG | IV administration at 6 escalating dose levels. |
| Sorafenib | DRUG | Oral administration at 400mg twice daily or 400mg once daily |
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 wi...
GC33 is an investigational small molecule developed by Roche Holding AG (ticker RHHBY) for hepatocellular carcinoma, the most common form of liver cancer. It has been studied in patients with advanced or metastatic disease. GC33 is also known as GC33(RO5137382). It remains in clinical development and is not described as an approved therapy.
GC33 is being studied for hepatocellular carcinoma, including advanced or metastatic liver cancer. Its clinical program enrolled adults with this condition across multiple countries. One trial also evaluated GC33 in combination with sorafenib. GC33 is investigational and has not been established as a marketed treatment for hepatocellular carcinoma.
GC33 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical studies of GC33 in hepatocellular carcinoma, including a Phase 2 trial and a Phase 1 combination trial. The drug is also designated GC33(RO5137382).
GC33 has reached Phase 2 in clinical development for hepatocellular carcinoma. Two trials have been conducted: one Phase 2 study and one Phase 1 study, both listed as completed. GC33 is investigational, and the available information does not indicate that it is FDA approved.
GC33 has been evaluated in two completed trials. NCT01507168 was a Phase 2 study of GC33 (RO5137382) in patients with advanced or metastatic hepatocellular carcinoma, enrolling 185 participants across the United States, Europe, and Asia. NCT00976170 was a Phase 1 study of GC33 combined with sorafenib in advanced or metastatic liver cancer, enrolling 42 participants.
Yes, GC33 and GC33(RO5137382) refer to the same investigational agent. RO5137382 is the Roche compound designation used in trial listings, while GC33 is the shorter name. Both names appear in the titles of the completed Phase 2 and Phase 1 studies in hepatocellular carcinoma.