Phase 2
N=50
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01752933 ↗Enrolled (actual)
50
Serious AEs
44.0%
Results posted
Jul 2019
Primary outcome: Primary: Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib — 25.0; 24.4 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SGI-110 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Astex Pharmaceuticals, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib |
25.0; 24.4 | — |
| SECONDARY Safety and Tolerability of Guadecitabine |
1; 21; 4; 46 | — |
| SECONDARY Alpha Fetoprotein Response as a Result of Guadecitabine Administration |
0; 2 | — |
| SECONDARY Duration of Response |
262; 144 | — |
| SECONDARY Progression-free Survival |
55; 82.5 | — |
| SECONDARY Overall Survival |
294; 245 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Histological or cytological confirmed hepatocellular carcinoma with advanced stage disease
- Received prior sorafenib treatment, and showed evidence of disease progression, which is defined as Investigator verified radiologic progression, or intolerance of prior systemic therapy, which is defined as having had clinically significant adverse events that persisted despite one or more dose reductions or interruptions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Acceptable organ function
- Signed an approved informed consent
Exclusion Criteria
- Known hypersensitivity to SGI-110
- Adequate washout of prior radiation, chemotherapy or other locoregional therapy
- Abnormal left ventricular ejection fraction
- Uncontrolled ischemic heart disease or a history of congestive cardiac failure
- Known brain metastases
- Clinically evident ascites
- Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
- Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, non-metastatic prostate cancer with normal prostate-specific antigen (PSA) or other cancer from which the subject has been disease free for at least three years
- Known history of human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT01752933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.