ID

44505

Beschreibung

A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02279719

Link

https://clinicaltrials.gov/show/NCT02279719

Stichworte

Versionen (2)
  1. 18.05.20 18.05.20 -
  2. 27.09.21 27.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02279719

Englisch

Eligibility Hepatocellular Carcinoma NCT02279719

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed written informed consent must be obtained and documented according to international conference on harmonisation (ich) and local regulatory requirements
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. histologically or cytologically confirmed hepatocellular carcinoma that is metastatic, unresectable, or recurrent
Beschreibung

Metastatic hepatocellular carcinoma | Unresectable hepatocellular carcinoma | Recurrent Hepatocellular Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0744869
UMLS CUI [2]
C1112459
UMLS CUI [3]
C0861876
1. patients must not be candidates for curative resection
Beschreibung

Patients Inappropriate Excision Curative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728940
UMLS CUI [1,4]
C1276305
2. patients who have recurrent disease after having had one or more prior resections may be eligible, provided that they are not candidates for further curative resection
Beschreibung

Recurrent disease | Status post Excision Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0728940
UMLS CUI [2,3]
C1265611
3. patients who have recurrent hepatocellular carcinoma following hepatic transplantation are excluded
Beschreibung

Exclusion | Recurrent Hepatocellular Carcinoma Following Transplantation of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0861876
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0023911
3. patients must be candidates for sorafenib
Beschreibung

Patients Appropriate Sorafenib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1516119
4. must have had no previous systemic anti-cancer treatment, though previous loco-regional therapy is allowed:
Beschreibung

Cancer treatment Systemic Absent | Therapy Local-Regional allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1947913
UMLS CUI [2,3]
C0683607
a. prior treatment with any of the following is allowed: trans-arterial embolization, trans-arterial chemo-embolization, percutaneous ethanol injection, radio-embolization, radio-frequency ablation, or other ablation techniques
Beschreibung

Transarterial embolization | Transarterial Chemoembolization | Percutaneous ethanol injection therapy | Radioembolisation | Radiofrequency ablation | Ablation

Datentyp

boolean

Alias
UMLS CUI [1]
C3163695
UMLS CUI [2]
C3539919
UMLS CUI [3]
C1535909
UMLS CUI [4]
C2985560
UMLS CUI [5]
C0850292
UMLS CUI [6]
C0547070
5. must be child-pugh class a
Beschreibung

Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1]
C4050412
a. patients with uncontrolled massive ascites or presence of hepatic encephalopathy are excluded
Beschreibung

Exclusion Criteria | ASCITES MASSIVE Uncontrolled | Hepatic Encephalopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0741241
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0019151
6. ≥ 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
7. measurable disease as defined by response evaluation criteria in solid tumors (recist) 1.1
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
8. eastern cooperative oncology group (ecog) performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
9. male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last bbi608 or bbi503 dose
Beschreibung

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
10. females of childbearing potential must have a negative serum pregnancy test
Beschreibung

Childbearing Potential Serum pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
11. aspartate aminotransferase (ast) and alanine transaminase (alt) < 5.0 x the upper limit of normal (uln)
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
12. creatinine ≤ 1.5 x uln or creatinine clearance > 50 ml/min according to the cockcroft-gault estimation
Beschreibung

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
13. hemoglobin ≥ 8.5 mg/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
14. absolute neutrophil count ≥ 1.5 x 10^9/l
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
15. platelets ≥ 60 x 10^9/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
16. life expectancy ≥ 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous treatment with sorafenib
Beschreibung

Sorafenib Prior Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C1514463
2. patients with known hypersensitivity to sorafenib or any other component of sorafenib
Beschreibung

Hypersensitivity Sorafenib | Hypersensitivity Sorafenib Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1516119
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1516119
UMLS CUI [2,3]
C1705248
3. previous systemic anti-vascular endothelial growth factor (vegf) or any prior systemic anti-cancer therapy, including prior treatment with systemic agents such as regorafenib, ramucirumab, pazopanib, or experimental agents such as brivanib
Beschreibung

Vascular Endothelial Growth Factor Inhibitor Systemic therapy | Cancer treatment Systemic | regorafenib | ramucirumab | pazopanib | brivanib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4521299
UMLS CUI [1,2]
C1515119
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C2980094
UMLS CUI [4]
C2742502
UMLS CUI [5]
C1831796
UMLS CUI [6]
C2700604
4. have had a surgical procedure requiring general anesthesia or inpatient hospitalization for recovery less than 4 weeks prior to beginning protocol therapy
Beschreibung

Operative Surgical Procedure Requirement General Anesthesia | Hospitalization Recovery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0002915
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C2004454
a. patients who have recurrent hepatocellular carcinoma following liver transplantation are excluded, regardless of how long ago the transplantation occurred
Beschreibung

Recurrent Hepatocellular Carcinoma Following Transplantation of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0861876
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0023911
5. have had a loco-regional procedure for the treatment of hepatocellular carcinoma (such as a percutaneous, trans-arterial, or radio-ablative procedure) less than 4 weeks prior to beginning protocol therapy. protocol therapy may begin a minimum of 4 weeks after such a procedure provided the following criteria are met:
Beschreibung

Therapeutic procedure Local-Regional Liver carcinoma | Therapeutic procedure Percutaneous | Therapeutic procedure Transarterial | Radiofrequency ablation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1947913
UMLS CUI [1,3]
C2239176
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0522523
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0522522
UMLS CUI [4]
C0850292
1. there is progression of disease documented by recist 1.1
Beschreibung

Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
2. all adverse events from the procedure have resolved or have been deemed irreversible and the patient meets inclusion criteria
Beschreibung

Adverse events Resolved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1514893
6. any known symptomatic or untreated brain metastases requiring increase of steroid dose within 2 weeks prior to starting on study. patients with treated brain metastases must be stable for 4 weeks after completion of that treatment. patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. patients with known leptomeningeal metastases are excluded, even if treated
Beschreibung

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Untreated | Metastatic Malignant Neoplasm to the Leptomeninges

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C1704231
7. pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. significant gastrointestinal disorder(s), (e.g., crohn's disease, ulcerative colitis, extensive gastric and small intestine resection) such that, in the opinion of the treating investigator, absorption of oral medications may be impaired
Beschreibung

Gastrointestinal Diseases Impairing Drug absorption | Crohn Disease | Ulcerative Colitis | Gastrectomy Extensive | Small intestine excision Extensive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0678745
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
UMLS CUI [4,1]
C0017118
UMLS CUI [4,2]
C0205231
UMLS CUI [5,1]
C0192601
UMLS CUI [5,2]
C0205231
9. unable or unwilling to swallow bbi608, bbi503, or sorafenib capsules or tablets
Beschreibung

Lacking Able to swallow BBI608 Capsules | Lacking Able to swallow BBI503 Capsules | Lacking Able to swallow Sorafenib Capsules | Lacking Able to swallow BBI608 Tablets | Lacking Able to swallow BBI503 Tablets | Lacking Able to swallow Sorafenib Tablets

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C3272772
UMLS CUI [1,4]
C0006935
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712086
UMLS CUI [2,3]
C3641863
UMLS CUI [2,4]
C0006935
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712086
UMLS CUI [3,3]
C1516119
UMLS CUI [3,4]
C0006935
UMLS CUI [4,1]
C0332268
UMLS CUI [4,2]
C2712086
UMLS CUI [4,3]
C3272772
UMLS CUI [4,4]
C0039225
UMLS CUI [5,1]
C0332268
UMLS CUI [5,2]
C2712086
UMLS CUI [5,3]
C3641863
UMLS CUI [5,4]
C0039225
UMLS CUI [6,1]
C0332268
UMLS CUI [6,2]
C2712086
UMLS CUI [6,3]
C1516119
UMLS CUI [6,4]
C0039225
10. uncontrolled inter-current illness including, but not limited to: ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements (e.g. no reliable transportation)
Beschreibung

Comorbidity Uncontrolled | Communicable Disease | Wound, non-healed | Wound healed | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Lung disease | Resting Dyspnea | Dyspnea Exertion Mild | Communicable Diseases Uncontrolled | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0750433
UMLS CUI [4]
C0574776
UMLS CUI [5]
C0742758
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0003811
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0743330
UMLS CUI [10,1]
C0013404
UMLS CUI [10,2]
C0031807
UMLS CUI [10,3]
C2945599
UMLS CUI [11,1]
C0009450
UMLS CUI [11,2]
C0205318
UMLS CUI [12,1]
C0004936
UMLS CUI [12,2]
C0439801
UMLS CUI [12,3]
C0525058
UMLS CUI [13,1]
C0748872
UMLS CUI [13,2]
C0439801
UMLS CUI [13,3]
C0525058
11. subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that, in the opinion of the investigator, will not affect patient outcome in the setting of current hepatocellular carcinoma diagnosis
Beschreibung

Cancer Other Primary | Exception Skin carcinoma Resected Curative | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Solid Neoplasm Inactive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1521996
UMLS CUI [2,4]
C1276305
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0280100
UMLS CUI [4,3]
C0544452
12. abnormal ecgs which are clinically significant such as qt prolongation (qtc > 480 msec), clinically significant cardiac enlargement or hypertrophy, new bundle branch block, or signs of active ischemia. patients with evidence of prior infarction who are new york heart association (nyha) functional classes ii, iii, or iv are excluded, as are patients with marked arrhythmias such as wolff parkinson white pattern or complete atrioventricular (av) dissociation
Beschreibung

ECG abnormal | Prolonged QT interval | Prolonged QTc interval | Cardiomegaly | Bundle-Branch Block New | Signs Ischemia | Infarction New York Heart Association Classification | Cardiac Arrhythmia Marked | Wolff-Parkinson-White Syndrome | Atrioventricular dissociation Complete

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0151878
UMLS CUI [3]
C1560305
UMLS CUI [4]
C0018800
UMLS CUI [5,1]
C0006384
UMLS CUI [5,2]
C0205314
UMLS CUI [6,1]
C0311392
UMLS CUI [6,2]
C0022116
UMLS CUI [7,1]
C0021308
UMLS CUI [7,2]
C1275491
UMLS CUI [8,1]
C0003811
UMLS CUI [8,2]
C1706089
UMLS CUI [9]
C0043202
UMLS CUI [10,1]
C2882262
UMLS CUI [10,2]
C0205197
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Ähnliche Modelle

Eligibility Hepatocellular Carcinoma NCT02279719

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed written informed consent must be obtained and documented according to international conference on harmonisation (ich) and local regulatory requirements
boolean
C0021430 (UMLS CUI [1])
Metastatic hepatocellular carcinoma | Unresectable hepatocellular carcinoma | Recurrent Hepatocellular Carcinoma
Item
2. histologically or cytologically confirmed hepatocellular carcinoma that is metastatic, unresectable, or recurrent
boolean
C0744869 (UMLS CUI [1])
C1112459 (UMLS CUI [2])
C0861876 (UMLS CUI [3])
Patients Inappropriate Excision Curative
Item
1. patients must not be candidates for curative resection
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C1276305 (UMLS CUI [1,4])
Recurrent disease | Status post Excision Quantity
Item
2. patients who have recurrent disease after having had one or more prior resections may be eligible, provided that they are not candidates for further curative resection
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Exclusion | Recurrent Hepatocellular Carcinoma Following Transplantation of liver
Item
3. patients who have recurrent hepatocellular carcinoma following hepatic transplantation are excluded
boolean
C0680251 (UMLS CUI [1])
C0861876 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0023911 (UMLS CUI [2,3])
Patients Appropriate Sorafenib
Item
3. patients must be candidates for sorafenib
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1516119 (UMLS CUI [1,3])
Cancer treatment Systemic Absent | Therapy Local-Regional allowed
Item
4. must have had no previous systemic anti-cancer treatment, though previous loco-regional therapy is allowed:
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Transarterial embolization | Transarterial Chemoembolization | Percutaneous ethanol injection therapy | Radioembolisation | Radiofrequency ablation | Ablation
Item
a. prior treatment with any of the following is allowed: trans-arterial embolization, trans-arterial chemo-embolization, percutaneous ethanol injection, radio-embolization, radio-frequency ablation, or other ablation techniques
boolean
C3163695 (UMLS CUI [1])
C3539919 (UMLS CUI [2])
C1535909 (UMLS CUI [3])
C2985560 (UMLS CUI [4])
C0850292 (UMLS CUI [5])
C0547070 (UMLS CUI [6])
Child-Pugh Classification
Item
5. must be child-pugh class a
boolean
C4050412 (UMLS CUI [1])
Exclusion Criteria | ASCITES MASSIVE Uncontrolled | Hepatic Encephalopathy
Item
a. patients with uncontrolled massive ascites or presence of hepatic encephalopathy are excluded
boolean
C0680251 (UMLS CUI [1])
C0741241 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0019151 (UMLS CUI [3])
Age
Item
6. ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
7. measurable disease as defined by response evaluation criteria in solid tumors (recist) 1.1
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
8. eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
9. male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last bbi608 or bbi503 dose
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Childbearing Potential Serum pregnancy test negative
Item
10. females of childbearing potential must have a negative serum pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
11. aspartate aminotransferase (ast) and alanine transaminase (alt) < 5.0 x the upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
12. creatinine ≤ 1.5 x uln or creatinine clearance > 50 ml/min according to the cockcroft-gault estimation
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Hemoglobin measurement
Item
13. hemoglobin ≥ 8.5 mg/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
14. absolute neutrophil count ≥ 1.5 x 10^9/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
15. platelets ≥ 60 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Life Expectancy
Item
16. life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sorafenib Prior Therapy
Item
1. previous treatment with sorafenib
boolean
C1516119 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Hypersensitivity Sorafenib | Hypersensitivity Sorafenib Component
Item
2. patients with known hypersensitivity to sorafenib or any other component of sorafenib
boolean
C0020517 (UMLS CUI [1,1])
C1516119 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Vascular Endothelial Growth Factor Inhibitor Systemic therapy | Cancer treatment Systemic | regorafenib | ramucirumab | pazopanib | brivanib
Item
3. previous systemic anti-vascular endothelial growth factor (vegf) or any prior systemic anti-cancer therapy, including prior treatment with systemic agents such as regorafenib, ramucirumab, pazopanib, or experimental agents such as brivanib
boolean
C4521299 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C2980094 (UMLS CUI [3])
C2742502 (UMLS CUI [4])
C1831796 (UMLS CUI [5])
C2700604 (UMLS CUI [6])
Operative Surgical Procedure Requirement General Anesthesia | Hospitalization Recovery
Item
4. have had a surgical procedure requiring general anesthesia or inpatient hospitalization for recovery less than 4 weeks prior to beginning protocol therapy
boolean
C0543467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002915 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
Recurrent Hepatocellular Carcinoma Following Transplantation of liver
Item
a. patients who have recurrent hepatocellular carcinoma following liver transplantation are excluded, regardless of how long ago the transplantation occurred
boolean
C0861876 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0023911 (UMLS CUI [1,3])
Therapeutic procedure Local-Regional Liver carcinoma | Therapeutic procedure Percutaneous | Therapeutic procedure Transarterial | Radiofrequency ablation
Item
5. have had a loco-regional procedure for the treatment of hepatocellular carcinoma (such as a percutaneous, trans-arterial, or radio-ablative procedure) less than 4 weeks prior to beginning protocol therapy. protocol therapy may begin a minimum of 4 weeks after such a procedure provided the following criteria are met:
boolean
C0087111 (UMLS CUI [1,1])
C1947913 (UMLS CUI [1,2])
C2239176 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0522523 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0522522 (UMLS CUI [3,2])
C0850292 (UMLS CUI [4])
Disease Progression
Item
1. there is progression of disease documented by recist 1.1
boolean
C0242656 (UMLS CUI [1])
Adverse events Resolved
Item
2. all adverse events from the procedure have resolved or have been deemed irreversible and the patient meets inclusion criteria
boolean
C0877248 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Untreated | Metastatic Malignant Neoplasm to the Leptomeninges
Item
6. any known symptomatic or untreated brain metastases requiring increase of steroid dose within 2 weeks prior to starting on study. patients with treated brain metastases must be stable for 4 weeks after completion of that treatment. patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. patients with known leptomeningeal metastases are excluded, even if treated
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1704231 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
7. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gastrointestinal Diseases Impairing Drug absorption | Crohn Disease | Ulcerative Colitis | Gastrectomy Extensive | Small intestine excision Extensive
Item
8. significant gastrointestinal disorder(s), (e.g., crohn's disease, ulcerative colitis, extensive gastric and small intestine resection) such that, in the opinion of the treating investigator, absorption of oral medications may be impaired
boolean
C0017178 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0017118 (UMLS CUI [4,1])
C0205231 (UMLS CUI [4,2])
C0192601 (UMLS CUI [5,1])
C0205231 (UMLS CUI [5,2])
Lacking Able to swallow BBI608 Capsules | Lacking Able to swallow BBI503 Capsules | Lacking Able to swallow Sorafenib Capsules | Lacking Able to swallow BBI608 Tablets | Lacking Able to swallow BBI503 Tablets | Lacking Able to swallow Sorafenib Tablets
Item
9. unable or unwilling to swallow bbi608, bbi503, or sorafenib capsules or tablets
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C3272772 (UMLS CUI [1,3])
C0006935 (UMLS CUI [1,4])
C0332268 (UMLS CUI [2,1])
C2712086 (UMLS CUI [2,2])
C3641863 (UMLS CUI [2,3])
C0006935 (UMLS CUI [2,4])
C0332268 (UMLS CUI [3,1])
C2712086 (UMLS CUI [3,2])
C1516119 (UMLS CUI [3,3])
C0006935 (UMLS CUI [3,4])
C0332268 (UMLS CUI [4,1])
C2712086 (UMLS CUI [4,2])
C3272772 (UMLS CUI [4,3])
C0039225 (UMLS CUI [4,4])
C0332268 (UMLS CUI [5,1])
C2712086 (UMLS CUI [5,2])
C3641863 (UMLS CUI [5,3])
C0039225 (UMLS CUI [5,4])
C0332268 (UMLS CUI [6,1])
C2712086 (UMLS CUI [6,2])
C1516119 (UMLS CUI [6,3])
C0039225 (UMLS CUI [6,4])
Comorbidity Uncontrolled | Communicable Disease | Wound, non-healed | Wound healed | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Lung disease | Resting Dyspnea | Dyspnea Exertion Mild | Communicable Diseases Uncontrolled | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
10. uncontrolled inter-current illness including, but not limited to: ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements (e.g. no reliable transportation)
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0750433 (UMLS CUI [3])
C0574776 (UMLS CUI [4])
C0742758 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0743330 (UMLS CUI [9])
C0013404 (UMLS CUI [10,1])
C0031807 (UMLS CUI [10,2])
C2945599 (UMLS CUI [10,3])
C0009450 (UMLS CUI [11,1])
C0205318 (UMLS CUI [11,2])
C0004936 (UMLS CUI [12,1])
C0439801 (UMLS CUI [12,2])
C0525058 (UMLS CUI [12,3])
C0748872 (UMLS CUI [13,1])
C0439801 (UMLS CUI [13,2])
C0525058 (UMLS CUI [13,3])
Cancer Other Primary | Exception Skin carcinoma Resected Curative | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Solid Neoplasm Inactive
Item
11. subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that, in the opinion of the investigator, will not affect patient outcome in the setting of current hepatocellular carcinoma diagnosis
boolean
C1707251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1521996 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0280100 (UMLS CUI [4,2])
C0544452 (UMLS CUI [4,3])
ECG abnormal | Prolonged QT interval | Prolonged QTc interval | Cardiomegaly | Bundle-Branch Block New | Signs Ischemia | Infarction New York Heart Association Classification | Cardiac Arrhythmia Marked | Wolff-Parkinson-White Syndrome | Atrioventricular dissociation Complete
Item
12. abnormal ecgs which are clinically significant such as qt prolongation (qtc > 480 msec), clinically significant cardiac enlargement or hypertrophy, new bundle branch block, or signs of active ischemia. patients with evidence of prior infarction who are new york heart association (nyha) functional classes ii, iii, or iv are excluded, as are patients with marked arrhythmias such as wolff parkinson white pattern or complete atrioventricular (av) dissociation
boolean
C0522055 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C1560305 (UMLS CUI [3])
C0018800 (UMLS CUI [4])
C0006384 (UMLS CUI [5,1])
C0205314 (UMLS CUI [5,2])
C0311392 (UMLS CUI [6,1])
C0022116 (UMLS CUI [6,2])
C0021308 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
C0003811 (UMLS CUI [8,1])
C1706089 (UMLS CUI [8,2])
C0043202 (UMLS CUI [9])
C2882262 (UMLS CUI [10,1])
C0205197 (UMLS CUI [10,2])
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