NCT01752933

SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)

A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at 16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC after failure of prior sorafenib.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	SGI-110	SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2012-12-19
• Last updated: 2024-08-27
• Results posted: 2019-07-30

Locations

24 sites across 3 countries: United States, Canada, United Kingdom