A Phase 2 interventional study of SGI-110 in Hepatocellular Carcinoma, sponsored by Astex Pharmaceuticals, Inc.. Completed at 24 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Astex Pharmaceuticals, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
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.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's enrollment of 52 is close to the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Astex Pharmaceuticals, Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 6 (46%) have results posted.
First submitted before Astex Pharmaceuticals, Inc. became part of Otsuka Holdings Co., Ltd..
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
SGI-110 administered subcutaneously (SC) daily on Days 1 - 5 every 28 days
Drug: SGI-110
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
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).
Time frame: 16 weeks
Safety and Tolerability of Guadecitabine
Number of patients with serious adverse events and adverse events
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
Percentage of patients with best post baseline alpha fetoprotein reduction of 50% or more
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
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.
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
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.
Time frame: 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.
Time frame: Through completion of study survival follow-up, an average of 270 days.
A total of 68 patients were screened for enrollment in the study. Of these, 16 were screen failures. Reasons for screen failure included not meeting all eligibility criteria (14 patients) and withdrawal of consent (2 patients).
| Milestone | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Started | 4 | 46 |
| Completed | 0 | 0 |
| Not completed | 4 | 46 |
| Withdrew: Disease progression | 3 | 29 |
| Withdrew: Withdrawal by subject | 0 | 5 |
| Withdrew: Adverse event | 1 | 4 |
| Withdrew: Physician decision | 0 | 3 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Hepatocellular carcinoma not confirmed | 0 | 1 |
| Withdrew: Patient noncompliant | 0 | 1 |
| Withdrew: Patient unable to travel to appointments | 0 | 1 |
| Milestone | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Started | 4 | 46 |
| Completed | 0 | 0 |
| Not completed | 4 | 46 |
| Withdrew: Death | 4 | 34 |
| Withdrew: Sponsor terminated study/database lock | 0 | 7 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 2 |
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).
| percentage of patients | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib | 25.0 (0.6 to 80.6) | 24.4 (12.4 to 40.3) |
Number of patients with serious adverse events and adverse events
| Participants | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Serious Adverse Event | 1 | 21 |
| Adverse Event | 4 | 46 |
Percentage of patients with best post baseline alpha fetoprotein reduction of 50% or more
| Participants | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Alpha Fetoprotein Response as a Result of Guadecitabine Administration | 0 | 2 |
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.
| days | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Duration of Response | 262 | 144 (109.0 to 240.0) |
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.
| days | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Progression-free Survival | 55 (50.0 to 262.0) | 82.5 (57.0 to 113.0) |
Overall survival measured in days.
| days | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Overall Survival | 294 (103.0 to 683.0) | 245 (148.0 to 303.0) |
Collected over Treatment-emergent adverse events included events that first occurred or worsened after the first dose of study drug until 30 days after the last dose of study drug or the start of alternative anticancer treatment for HCC, whichever occurred first. Events that occurred more than 30 days after the last dose of study treatment or start of alternative cancer treatment were also considered treatment emergent if they were both serious and related to treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Guadecitabine 60 mg/m^2 | 4/4 (100%) | 1/4 (25%) | 4/4 (100%) |
| Guadecitabine 45 mg/m^2 | 34/46 (73.9%) | 21/46 (45.7%) | 46/46 (100%) |
| Event | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/4 | 5/46 |
| Abdominal painGastrointestinal disorders | 0/4 | 2/46 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/4 | 2/46 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/4 | 2/46 |
| AnaemiaBlood and lymphatic system disorders | 0/4 | 1/46 |
| Atrial fibrillationCardiac disorders | 0/4 | 1/46 |
| Adrenal haemorrhageEndocrine disorders | 0/4 | 1/46 |
| AscitesGastrointestinal disorders | 0/4 | 1/46 |
| DiarrhoeaGastrointestinal disorders | 0/4 | 1/46 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/4 | 1/46 |
| Event | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 4/4 | 39/46 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/4 | 20/46 |
| FatigueGeneral disorders | 3/4 | 24/46 |
| DiarrhoeaGastrointestinal disorders | 2/4 | 11/46 |
| NauseaGastrointestinal disorders | 2/4 | 11/46 |
| Injection site erythemaGeneral disorders | 2/4 | 3/46 |
| Injection site painGeneral disorders | 2/4 | 21/46 |
| Bone painMusculoskeletal and connective tissue disorders | 2/4 | 2/46 |
| DysgeusiaNervous system disorders | 2/4 | 1/46 |
| HeadacheNervous system disorders | 2/4 | 6/46 |
The total number of subjects presented for Baseline Analysis (50 subjects) is less than the total presented in Participant Flow (52 subjects) because 2 subjects were withdrawn from the study prior to receiving treatment and thus were not assigned to a treatment group.
| Age, Categorical(Participants) | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 33 | 37 |
| >=65 years | 0 | 13 | 13 |
| Sex: Female, Male(Participants) | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 | Total |
|---|---|---|---|
| Female | 0 | 7 | 7 |
| Male | 4 | 39 | 43 |
| Region of Enrollment(participants) | Guadecitabine 60 mg/m^2 | Guadecitabine 45 mg/m^2 | Total |
|---|---|---|---|
| Canada | 0 | 7 | 7 |
| United States | 4 | 39 | 43 |
The record gives a start of Dec 2012, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2019, 3 years 10 months after primary completion. A results delay was requested in Jan 2017.
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Guadecitabine