SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
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|ClinicalTrials.gov Identifier: NCT01752933|
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : January 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: SGI-110||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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
- Assess the disease control rate (DCR) at 16 weeks for patients treated with SGI-110 after failure of sorafenib [ Time Frame: 18 months ]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 ]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 ]Change in alpha fetoprotein levels from pre-treatment levels
- Duration of response [ Time Frame: 18 months ]Duration of response as measured in weeks.
- Progression-free survival [ Time Frame: 18 months ]Progression-free survival measured in weeks.
- Overall survival [ Time Frame: 18 months ]Overall survival measured in weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752933
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