- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01752933
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
January 13, 2020 updated by: Astex Pharmaceuticals, Inc.
A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib
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 Overview
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia and Vancouver General Hospital
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital Cancer Center
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook HealthScience Centre
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 3J4
- CHUM Hopital St-Luc
-
Sherbrooke, Quebec, Canada, J1N 5N4
- Centre Hospitalier Universitaire de Sherbrooke
-
-
-
-
-
Liverpool, United Kingdom
- University of Liverpool Clatterbridge Cancer Center
-
London, United Kingdom, WC1E 6BT
- University College London
-
London, United Kingdom, EC1V 4AD
- Cambridge University Hospitals NHS Foundation Trust
-
London, United Kingdom, W12 0NN
- Imperial College Healthcare NHS Foundation Trust
-
-
-
-
California
-
Duarte, California, United States, 91010
- City of Hope National Medical Center
-
Los Angeles, California, United States, 90033
- USC Norris Comprehensive Cancer Center
-
Sacramento, California, United States, 95817
- UC Davis Comprehensive Cancer Center
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University: Robert H. Lurie Comprehensive Cancer Center
-
-
Kentucky
-
Louisville, Kentucky, United States, 40201
- University of Louisville James Graham Brown Cancer Center
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Comprehensive Cancer Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina, Hollings Cancer Center
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- The Jones Clinic, PC
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
-
Dallas, Texas, United States, 75230
- Mary Crowley Medical Research Center
-
-
Washington
-
Seattle, Washington, United States, 98122
- Swedish Cancer Institute
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- UW Carbone Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SGI-110
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
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.
|
From time of first response until disease progression or date of death due to any cause, whichever occurred earlier; an average of 192 days.
|
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.
|
Through completion of response assessments (i.e., until disease progression or treatment discontinuation), an average of 112 days.
|
Overall Survival
Time Frame: Through completion of study survival follow-up, an average of 270 days.
|
Overall survival measured in days.
|
Through completion of study survival follow-up, an average of 270 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
December 17, 2012
First Submitted That Met QC Criteria
December 17, 2012
First Posted (Estimate)
December 19, 2012
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGI-110-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatocellular Carcinoma
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditionsUnited States
-
Roswell Park Cancer InstituteMerck Sharp & Dohme LLCActive, not recruitingAdvanced Adult Hepatocellular Carcinoma | Child-Pugh Class A | Stage III Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular...United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | BCLC Stage C Hepatocellular Carcinoma | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | BCLC Stage B Hepatocellular Carcinoma and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI); Genentech, Inc.RecruitingUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnresectable Hepatocellular Carcinoma | Advanced Adult Hepatocellular Carcinoma | Recurrent Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma AJCC v7 | Stage IIIC Hepatocellular Carcinoma AJCC v7 | Stage IV Hepatocellular Carcinoma AJCC v7 | Stage III Hepatocellular Carcinoma AJCC v7 and other conditionsUnited States, Canada, Puerto Rico
-
Edward KimBristol-Myers Squibb; National Cancer Institute (NCI)TerminatedUnresectable Hepatocellular Carcinoma | Stage III Hepatocellular Carcinoma AJCC v8 | Stage IIIA Hepatocellular Carcinoma AJCC v8 | Stage IV Hepatocellular Carcinoma AJCC v8 | Stage IVA Hepatocellular Carcinoma AJCC v8 | Stage IVB Hepatocellular Carcinoma AJCC v8 | Stage IIIB Hepatocellular Carcinoma... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingAdvanced Hepatocellular Carcinoma | BCLC Stage B Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | Metastatic Hepatocellular Carcinoma | BCLC Stage A Hepatocellular CarcinomaUnited States
-
Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI)CompletedStage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular CarcinomaUnited States
Clinical Trials on SGI-110
-
Astex Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Myeloid Dysplastic SyndromeUnited States, Taiwan, Korea, Republic of, Canada, Spain, Japan, Italy, Austria, Denmark
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingHigh Risk Myelodysplastic SyndromeUnited States
-
Weill Medical College of Cornell UniversityAstex Pharmaceuticals, Inc.CompletedMyeloproliferative NeoplasmsUnited States
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Groupe Francophone des MyelodysplasiesUnknownAcute Myeloid Leukemia | Myelodysplastic SyndromesFrance
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAcute Myeloid Leukemia | Chronic Myelomonocytic Leukemia | Myelodysplastic Syndrome | Recurrent Acute Myeloid Leukemia | Recurrent Myelodysplastic SyndromeUnited States
-
Groupe Francophone des MyelodysplasiesAstex Pharmaceuticals, Inc.Completed
-
Shadia Jalal, MDAstex Pharmaceuticals, Inc.; Indiana University School of MedicineCompletedSmall Cell Lung Cancer | Extensive-stage Small Cell Lung CancerUnited States
-
Ajjai Alva, MDAstraZeneca; Big Ten Cancer Research ConsortiumActive, not recruitingKidney Cancer | Clear Cell Renal Cell Carcinoma | Advanced Kidney CancerUnited States
-
Astex Pharmaceuticals, Inc.CompletedLeukemia, Myeloid, AcuteUnited States, Spain, Korea, Republic of, Taiwan, Australia, Canada, Denmark, Hungary, Japan, Finland, Italy, Serbia, Czechia, France, Germany, Sweden, Netherlands, Poland, Russian Federation, Austria, United Kingdom, Romania, Belgium, Bulgar...