Clinical trial NCT01752933: SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Astex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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:

1. 18 years of age or older
2. Histological or cytological confirmed hepatocellular carcinoma with advanced stage disease
3. 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
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
5. Acceptable organ function
6. Signed an approved informed consent

Exclusion Criteria:

1. Known hypersensitivity to SGI-110
2. Adequate washout of prior radiation, chemotherapy or other locoregional therapy
3. Abnormal left ventricular ejection fraction
4. Uncontrolled ischemic heart disease or a history of congestive cardiac failure
5. Known brain metastases
6. Clinically evident ascites
7. Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
8. 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
9. Known history of human immunodeficiency virus (HIV)

Primary outcomes:
measure: Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib
timeFrame: 16 weeks
Secondary outcomes:
measure: Safety and Tolerability of Guadecitabine
timeFrame: 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
measure: Alpha Fetoprotein Response as a Result of Guadecitabine Administration
timeFrame: 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
measure: Duration of Response
timeFrame: From time of first response until disease progression or date of death due to any cause, whichever occurred earlier; an average of 192 days.
measure: Progression-free Survival
timeFrame: Through completion of response assessments (i.e., until disease progression or treatment discontinuation), an average of 112 days.
measure: Overall Survival
timeFrame: Through completion of study survival follow-up, an average of 270 days.
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University: Robert H. Lurie Comprehensive Cancer Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville James Graham Brown Cancer Center
state: Kentucky
city: New York
country: United States
facility: Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina, Hollings Cancer Center
state: South Carolina
city: Germantown
country: United States
facility: The Jones Clinic, PC
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Madison
country: United States
facility: UW Carbone Cancer Center
state: Wisconsin
city: Vancouver
country: Canada
facility: University of British Columbia and Vancouver General Hospital
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook HealthScience Centre
state: Ontario
city: Montreal
country: Canada
facility: CHUM Hopital St-Luc
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Liverpool
country: United Kingdom
facility: University of Liverpool Clatterbridge Cancer Center
city: London
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London
Study officials:
References: