SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib|
- Assess the disease control rate (DCR) at 16 weeks for patients treated with SGI-110 after failure of sorafenib [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Percentage of patients achieving a best overall response of complete response or partial response and stable disease at 16 weeks
- Assess safety and tolerability of SGI-110 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Number of patients with serious adverse events and adverse events
- Determine alpha fetoprotein response as a result of SGI-110 administration [ Time Frame: 18 months ] [ Designated as safety issue: No ]Change in alpha fetoprotein levels from pre-treatment levels
- Duration of response [ Time Frame: 18 months ] [ Designated as safety issue: No ]Duration of response as measured in weeks.
- Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]Progression-free survival measured in weeks.
- Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]Overall survival measured in weeks.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
SGI-110 administered subcutaneously daily on Days 1 - 5 every 28 days
SGI-110 will be administered by subcutaneously on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity
|Contact: Medpace Recruitment Center||1-866-872-2349|
|United States, Washington|
|Swedish Cancer Institute||Recruiting|
|Seattle, Washington, United States, 98122|
|Contact: Philip Gold, MD 206-386-2242|
|Principal Investigator: Philip Gold, MD|