Hepatocellular CarcinomaPhase 2NCT01752933
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
A Phase 2 study testing SGI-110 in people with Hepatocellular Carcinoma, run by Astex Pharmaceuticals, Inc. at 24 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SGI-110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Dec 2012to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States15 sites
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, 29425
Northwestern University: Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mary Crowley Medical Research Center
Dallas, Texas, 75230
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
City of Hope National Medical Center
Duarte, California, 91010
The Jones Clinic, PC
Germantown, Tennessee, 38138
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40201
UW Carbone Cancer Center
Madison, Wisconsin, 53792
Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Swedish Cancer Institute
Seattle, Washington, 98122
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Canada5 sites
CHUM Hopital St-Luc
Montreal, Quebec, H2X 3J4
The Ottawa Hospital Cancer Center
Ottawa, Ontario, K1H 8L6
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1N 5N4
Sunnybrook HealthScience Centre
Toronto, Ontario, M4N 3M5
University of British Columbia and Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
United Kingdom4 sites
University of Liverpool Clatterbridge Cancer Center
Liverpool
Cambridge University Hospitals NHS Foundation Trust
London, EC1V 4AD
Imperial College Healthcare NHS Foundation Trust
London, W12 0NN
University College London
London, WC1E 6BT
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SGI-110
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGI-110Drug
SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| SGI-110 | Experimental | SGI-110 administered subcutaneously (SC) daily on Days 1 - 5 every 28 days Receives: Drug: SGI-110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib
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).
Measured: 16 weeks
Secondary outcomes (5)
Safety and Tolerability of Guadecitabine
Number of patients with serious adverse events and adverse events
Measured: 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
Percentage of patients with best post baseline alpha fetoprotein reduction of 50% or more
Measured: 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
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.
Measured: 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
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.
Measured: Through completion of response assessments (i.e., until disease progression or treatment discontinuation), an average of 112 days.
Overall Survival
Overall survival measured in days.
Measured: Through completion of study survival follow-up, an average of 270 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752933
- Sponsor's protocol ID
- SGI-110-03
- Status last verified
- Jul 2024
- First submitted
- 17 Dec 2012
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC) Subjects Who Failed Prior Treatment With Sorafenib
- ClinicalTrials.gov ID
- NCT01752933
- Acronym / sponsor ID
- SGI-110-03
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGI-110 | Experimental | Drug: SGI-110SGI-110 administered subcutaneously (SC) daily on Days 1 - 5 every 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGI-110SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity | Drug | SGI-110 |
Primary outcome
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).
5 secondary outcomes
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
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
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.
Progression-free Survival
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGI-110 in people with Hepatocellular Carcinoma, run by Astex Pharmaceuticals, Inc. at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.