drugset / Trial / NCT01752933

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

NCT01752933

Phase 2 Completed 52 enrolled Astex Pharmaceuticals, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-12
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Guadecitabine Oligonucleotide (other) Subcutaneous