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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGI-110 | Experimental | SGI-110 administered subcutaneously (SC) daily on Days 1 - 5 every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGI-110 | Drug | SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Guadecitabine | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| USC Norris Comprehensive Cancer Center |
Of the 52 patients enrolled in the study, 2 did not receive any treatment. Reasons for not receiving treatment included death for one patient and no longer meeting eligibility criteria for the second patient.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Guadecitabine 60 mg/m^2 | Guadecitabine (SGI-110) 60 mg/m^2 subcutaneously (SC) on Days 1 - 5 of each 28-day cycle |
| FG001 | Guadecitabine 45 mg/m^2 | Guadecitabine (SGI-110) 45 mg/m^2 SC on Days 1 - 5 of each 28-day cycle |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment |
|
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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 | 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 | 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 | Overall survival measured in days. | Through completion of study survival follow-up, an average of 270 days. |
| Los Angeles |
| California |
| 90033 |
| United States |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Northwestern University: Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | United States |
| University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky | 40201 | United States |
| Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Medical University of South Carolina, Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| The Jones Clinic, PC | Germantown | Tennessee | 38138 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75230 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98122 | United States |
| UW Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| University of British Columbia and Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| The Ottawa Hospital Cancer Center | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook HealthScience Centre | Toronto | Ontario | M4N 3M5 | Canada |
| CHUM Hopital St-Luc | Montreal | Quebec | H2X 3J4 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1N 5N4 | Canada |
| University of Liverpool Clatterbridge Cancer Center | Liverpool | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | London | EC1V 4AD | United Kingdom |
| Imperial College Healthcare NHS Foundation Trust | London | W12 0NN | United Kingdom |
| University College London | London | WC1E 6BT | United Kingdom |
|
| COMPLETED | Treatment continued as long as patient was benefitting from treatment with manageable side effects |
|
| NOT COMPLETED |
|
|
| Overall Study and Follow-up |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Guadecitabine 60 mg/m^2 | Guadecitabine (SGI-110) 60 mg/m^2 SC on Days 1 - 5 of each 28-day cycle |
| BG001 | Guadecitabine 45 mg/m^2 | Guadecitabine (SGI-110) 45 mg/m^2 SC on Days 1 - 5 of each 28-day cycle |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Patients who met major inclusion/exclusion criteria and followed the study protocol without a significant deviation (1 patient excluded because did not have confirmed HCC; 4 patients excluded because did not have a Week 16 assessment). | Posted | Number | 95% Confidence Interval | percentage of patients | 16 weeks |
|
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| ||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability of Guadecitabine | Number of patients with serious adverse events and adverse events | Includes all patients who received any guadecitabine | Posted | Count of Participants | Participants | 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 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Alpha Fetoprotein Response as a Result of Guadecitabine Administration | Percentage of patients with best post baseline alpha fetoprotein reduction of 50% or more | Includes all patients who received any guadecitabine | Posted | Count of Participants | Participants | 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 |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Assessed for patients who had a clinical response | Posted | Median | 95% Confidence Interval | days | From time of first response until disease progression or date of death due to any cause, whichever occurred earlier; an average of 192 days. |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Includes all patients who received any guadecitabine | Posted | Median | 95% Confidence Interval | days | Through completion of response assessments (i.e., until disease progression or treatment discontinuation), an average of 112 days. |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival measured in days. | Includes all patients who received any guadecitabine | Posted | Median | 95% Confidence Interval | days | Through completion of study survival follow-up, an average of 270 days. |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guadecitabine 60 mg/m^2 | Guadecitabine (SGI-110) 60 mg/m^2 SC on Days 1 - 5 of each 28-day cycle | 4 | 4 | 1 | 4 | 4 | 4 |
| EG001 | Guadecitabine 45 mg/m^2 | Guadecitabine (SGI-110) 45 mg/m^2 SC on Days 1 - 5 of each 28-day cycle | 34 | 46 | 21 | 46 | 46 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Adrenal haemorrhage | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Early satiety | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Hypoalbuminemia | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gingival swelling | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Glossodynia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
The original starting dose of 60 mg/m^2 guadecitabine was reduced to 45 mg/m^2 after dose-limiting toxicities occurred in the first 4 patients.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho Central | Taiho Oncology, Inc. | 609-250-7336 | clinicaltrialinfo@taihooncology.com |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C580831 | guadecitabine |
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| Withdrawal by Subject |
|
| Lost to Follow-up |
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| >=65 years |
|
| Male |
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| United States |
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