drugset / Trial / NCT01752933
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guadecitabine | Oligonucleotide (other) | — | Subcutaneous |