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GC33

Phase 2

Carcinoma, Hepatocellular | Small molecule | Oncology |Roche Holding AG|Last Updated: Apr 3, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment185

FDA Designations

No designations recorded

Clinical trial landscape

GC33 · 1 trial · 1 indication

Phase 2 1
NCT01507168A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular CarcinomaCarcinoma, Hepatocellular
COMPLETED185 Analytics
PHASE2COMPLETED
A Study of GC33 (RO5137382) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Carcinoma, HepatocellularUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival (tumor assessments according to RECIST criteria)
approximately 24 months

Secondary Endpoints

Overall survival
approximately 32 months
Time to progression (TTP): Time from randomization to first documented disease progression
approximately 24 months
Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks
approximately 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
GC33 (RO5137382)EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGiv Days 1 and 8, and every 2 weeks thereafter
GC33DRUG1600 mg iv Day 1 and 8, and every 2 weeks thereafter
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites57

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...

Countries:United StatesBelgiumFranceGermanyHong KongItalyJapanNew ZealandSingaporeSouth KoreaSpainTaiwanUnited Kingdom
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Frequently asked questions about GC33

What is GC33 used for?

GC33 is an investigational drug being studied for the treatment of advanced or metastatic hepatocellular carcinoma, a type of liver cancer. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being developed by Roche Holding AG.

Who makes GC33?

GC33 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded over-the-counter under the ticker symbol RHHBY. The drug is currently in Phase 2 clinical trials for hepatocellular carcinoma.

What phase is GC33 in?

GC33 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. A Phase 2 study of GC33 in patients with advanced or metastatic hepatocellular carcinoma has been completed.

What clinical trials is GC33 in?

GC33 has been studied in one clinical trial, identified as NCT01507168. This was a Phase 2, randomized, double-blind, placebo-controlled study in patients with advanced or metastatic hepatocellular carcinoma. The trial enrolled 185 participants and has been completed.

Is GC33 the same as RO5137382?

Yes, GC33 is also known as RO5137382. In clinical trial NCT01507168, the drug is referred to as GC33 (RO5137382). This alternative name may be used in scientific literature and regulatory documents.