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
Results First Posted : July 30, 2019
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: SGI-110||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 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 (SC) daily on Days 1 - 5 every 28 days
SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity
- Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib [ Time Frame: 16 weeks ]Percentage of patients achieving a best overall response of complete response (CR) or partial response (PR) plus subjects with stable disease at 16 weeks after the start of treatment. Response was assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for target and non-target lesions using computed tomography (CT) or magnetic resonance imaging (MRI) as follows: Complete Response (CR), disappearance of all target lesions, disappearance of all non-target lesions, and normalization of tumor marker level; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions from baseline; Progressive Disease (PD), at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions, and unequivocal progression of non-target lesions; Stable Disease, neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD (Eisenhauer et al. 2009, Eur. J. Cancer 45:228-247).
- Safety and Tolerability of Guadecitabine [ Time Frame: Varied by patient (median number of treatment cycles was 2.0 (range 2-8) in 60 mg/m^2 group, and 4.0 (range 1-13) in 45 mg/m^2 group ]Number of patients with serious adverse events and adverse events
- Alpha Fetoprotein Response as a Result of Guadecitabine Administration [ Time Frame: Varied by patient (median number of treatment cycles was 2.0 (range 2-8) in 60 mg/m^2 group, and 4.0 (range 1-13) in 45 mg/m^2 group ]Percentage of patients with best post baseline alpha fetoprotein reduction of 50% or more
- Duration of Response [ Time Frame: From time of first response until disease progression or date of death due to any cause, whichever occurred earlier; an average of 192 days. ]Duration of response as measured in days. Included subjects with a complete response or partial response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Progression-free Survival [ Time Frame: Through completion of response assessments (i.e., until disease progression or treatment discontinuation), an average of 112 days. ]Progression-free survival measured in days. Progression-free survival was defined as the time interval from the date of the first dose of study treatment to the earlier of 1) documented radiologic progression per RECIST v1.1 or clinical progression, or 2) death due to any cause.
- Overall Survival [ Time Frame: Through completion of study survival follow-up, an average of 270 days. ]Overall survival measured in days.
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