ID

35187

Description

Phase 1 Study of GEN0101 in Patients With Recurrence of CRPC; ODM derived from: https://clinicaltrials.gov/show/NCT02502994

Link

https://clinicaltrials.gov/show/NCT02502994

Keywords

Versions (1)
  1. 2/22/19 2/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Castration Resistant Prostate Cancer NCT02502994

English

Eligibility Castration Resistant Prostate Cancer NCT02502994

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients providing a written informed consent by voluntary agreement.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. age 20 =< and =<85 years old at the time of informed consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. have a diagnosis of malignant tumor as confirmed by histology or cytology.
Description

Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0006826
4. have a diagnosis of recurrence of castration resistant prostate cancer and meet the following condition
Description

Castration-Resistant Prostatic Cancer Recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C3658266
UMLS CUI [1,2]
C0034897
inapplicable to the standard treatment, ineffective through the criteria of the prostate cancer clinical trials working group (pcwg2) or refuse the standard treatment
Description

Standard therapy Inappropriate | Standard therapy ineffective | Standard therapy Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C3242229
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C1705116
more than 6 week between the end date of the standard treatment and the registration date when the standard treatment has been ineffective
Description

Standard therapy ineffective | Time Interval Standard therapy Study Registration Date

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C3242229
UMLS CUI [2,1]
C0872291
UMLS CUI [2,2]
C2936643
UMLS CUI [2,3]
C2985881
5. serum psa <100 ng/ml at the screening visit
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
6. expected survival period is more than 8 weeks after planned start date of investigational product
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
7. ecog performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. have an injectable intraprostatic lesion confirmed by histologic examination
Description

Intraprostatic injection Possible Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C1555364
UMLS CUI [1,2]
C0332149
UMLS CUI [1,3]
C0221198
9. the marrow function, liver function and the kidney function must be kept as follows at the screening visit (1) leukocyte >= 3,000/mcl (2) neutrophil >=1,500/mcl (3) platelet >=75,000/mcl (4) hemoglobin >=8.0 g/dl. (5) ast =<100 iu/l (6) alt =<100 iu/l (7) total bilirubin =<2.5 mg/dl (8) serum creatinine =<2.5 mg/dl
Description

Bone Marrow function | Liver function | Renal function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0023508
UMLS CUI [5]
C0200633
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0518015
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201836
UMLS CUI [10]
C1278039
UMLS CUI [11]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have multiple brain metastases
Description

Metastatic malignant neoplasm to brain Multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0439064
2. positive result of the prick test of gen0101
Description

Other Coding | Skin prick test

Data type

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0430561
3. have serious complications such as uncontrolled active infection
Description

Complications Serious | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
4. received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before the planned registration date however the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-rankl antigen antibody is are not included in the systemic chemotherapy.
Description

Systemic Chemotherapy | Systemic Radiation Therapy | Immunotherapy Systemic | Exception Hormone Therapy | Exception Estramustine | Exception Enzalutamide | Exception Abiraterone | Exception Diphosphonates | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2]
C2985381
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0279025
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0014921
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C3496793
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0754011
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0012544
UMLS CUI [9]
C3846158
5. received another investigational medical product within 4 weeks before the informed concent
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
6. had a history of malignancy other than prostate cancer, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration
Description

Cancer Other | Exception Relapse Free Duration | Exception Neoplasm Metastasis Free Duration

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0035020
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0027627
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
7. have an active autoimmune disease
Description

Autoimmune Disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
8. receiving systemic administration of glucocorticosteroid which restrains immunity response, except for the administration for a long period (over 6 months) of the low dose (equivalent to under 10 mg/day oral prednisolone).
Description

Glucocorticoids, Systemic | Exception Administration Low dose Long-term

Data type

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0445550
UMLS CUI [2,4]
C0443252
9. had a history of the autologous or homogeneous organ or tissue transplantation (receiving immunosuppressive medication)
Description

Organ Transplantation Autologous | Organ Transplantation Homogeneous | Tissue Transplantation Autologous | Tissue Transplantation Homogeneous | Receiving Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0439859
UMLS CUI [2,1]
C0029216
UMLS CUI [2,2]
C1881065
UMLS CUI [3,1]
C0080232
UMLS CUI [3,2]
C0439859
UMLS CUI [4,1]
C0080232
UMLS CUI [4,2]
C1881065
UMLS CUI [5,1]
C1514756
UMLS CUI [5,2]
C0021081
10. pt(%) less than 10% of the lower limit of normal or aptt more than 1.5 times of the upper limit of normal of local reference range at the screening visit
Description

Prothrombin time assay | Partial thromboplastin time increased

Data type

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0240671
11. positive result of the hepatitis b surface antigen, hcv antibody or hiv test at the screening visit
Description

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
12. inappropriate to be enrolled in this study judged by the investigators
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Castration Resistant Prostate Cancer NCT02502994

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. patients providing a written informed consent by voluntary agreement.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age 20 =< and =<85 years old at the time of informed consent
boolean
C0001779 (UMLS CUI [1])
Malignant Neoplasm
Item
3. have a diagnosis of malignant tumor as confirmed by histology or cytology.
boolean
C0006826 (UMLS CUI [1])
Castration-Resistant Prostatic Cancer Recurrence
Item
4. have a diagnosis of recurrence of castration resistant prostate cancer and meet the following condition
boolean
C3658266 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Standard therapy Inappropriate | Standard therapy ineffective | Standard therapy Refused
Item
inapplicable to the standard treatment, ineffective through the criteria of the prostate cancer clinical trials working group (pcwg2) or refuse the standard treatment
boolean
C2936643 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C3242229 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Standard therapy ineffective | Time Interval Standard therapy Study Registration Date
Item
more than 6 week between the end date of the standard treatment and the registration date when the standard treatment has been ineffective
boolean
C2936643 (UMLS CUI [1,1])
C3242229 (UMLS CUI [1,2])
C0872291 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C2985881 (UMLS CUI [2,3])
Prostate specific antigen measurement
Item
5. serum psa <100 ng/ml at the screening visit
boolean
C0201544 (UMLS CUI [1])
Life Expectancy
Item
6. expected survival period is more than 8 weeks after planned start date of investigational product
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Intraprostatic injection Possible Lesion
Item
8. have an injectable intraprostatic lesion confirmed by histologic examination
boolean
C1555364 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
Bone Marrow function | Liver function | Renal function | White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
9. the marrow function, liver function and the kidney function must be kept as follows at the screening visit (1) leukocyte >= 3,000/mcl (2) neutrophil >=1,500/mcl (3) platelet >=75,000/mcl (4) hemoglobin >=8.0 g/dl. (5) ast =<100 iu/l (6) alt =<100 iu/l (7) total bilirubin =<2.5 mg/dl (8) serum creatinine =<2.5 mg/dl
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0023508 (UMLS CUI [4])
C0200633 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0518015 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C1278039 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Multiple
Item
1. have multiple brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
Other Coding | Skin prick test
Item
2. positive result of the prick test of gen0101
boolean
C3846158 (UMLS CUI [1])
C0430561 (UMLS CUI [2])
Complications Serious | Communicable Disease Uncontrolled
Item
3. have serious complications such as uncontrolled active infection
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Systemic Chemotherapy | Systemic Radiation Therapy | Immunotherapy Systemic | Exception Hormone Therapy | Exception Estramustine | Exception Enzalutamide | Exception Abiraterone | Exception Diphosphonates | Other Coding
Item
4. received systemic chemotherapy, radiotherapy or immunotherapy within 6 weeks before the planned registration date however the hormone therapy except for the estramustine, enzalutamide and abiraterone, bisphosphonate and anti-rankl antigen antibody is are not included in the systemic chemotherapy.
boolean
C1883256 (UMLS CUI [1])
C2985381 (UMLS CUI [2])
C0021083 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0014921 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C3496793 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0754011 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0012544 (UMLS CUI [8,2])
C3846158 (UMLS CUI [9])
Investigational New Drugs
Item
5. received another investigational medical product within 4 weeks before the informed concent
boolean
C0013230 (UMLS CUI [1])
Cancer Other | Exception Relapse Free Duration | Exception Neoplasm Metastasis Free Duration
Item
6. had a history of malignancy other than prostate cancer, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
Autoimmune Disease
Item
7. have an active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Glucocorticoids, Systemic | Exception Administration Low dose Long-term
Item
8. receiving systemic administration of glucocorticosteroid which restrains immunity response, except for the administration for a long period (over 6 months) of the low dose (equivalent to under 10 mg/day oral prednisolone).
boolean
C3540777 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0445550 (UMLS CUI [2,3])
C0443252 (UMLS CUI [2,4])
Organ Transplantation Autologous | Organ Transplantation Homogeneous | Tissue Transplantation Autologous | Tissue Transplantation Homogeneous | Receiving Immunosuppressive Agents
Item
9. had a history of the autologous or homogeneous organ or tissue transplantation (receiving immunosuppressive medication)
boolean
C0029216 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0029216 (UMLS CUI [2,1])
C1881065 (UMLS CUI [2,2])
C0080232 (UMLS CUI [3,1])
C0439859 (UMLS CUI [3,2])
C0080232 (UMLS CUI [4,1])
C1881065 (UMLS CUI [4,2])
C1514756 (UMLS CUI [5,1])
C0021081 (UMLS CUI [5,2])
Prothrombin time assay | Partial thromboplastin time increased
Item
10. pt(%) less than 10% of the lower limit of normal or aptt more than 1.5 times of the upper limit of normal of local reference range at the screening visit
boolean
C0033707 (UMLS CUI [1])
C0240671 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity
Item
11. positive result of the hepatitis b surface antigen, hcv antibody or hiv test at the screening visit
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Study Subject Participation Status Inappropriate
Item
12. inappropriate to be enrolled in this study judged by the investigators
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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