ID

31554

Beskrivning

Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00460031

Länk

https://clinicaltrials.gov/show/NCT00460031

Nyckelord

Versioner (1)
  1. 2018-09-03 2018-09-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00460031

Engelsk

Eligibility Prostate Cancer NCT00460031

1 Formulär  
Criteria
Beskrivning

Criteria

progressive disease after androgen deprivation.
Beskrivning

Progressive Disease | Status post Antiandrogen therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0279492
exclusion criteria prior systemic chemotherapy for hormone refractory prostate cancer. prior neoadjuvant and adjuvant chemotherapy are allowed when completed at least 12 months prior to enrollment.
Beskrivning

Exclusion Criteria | Systemic Chemotherapy Hormone refractory prostate cancer | Chemotherapy Neoadjuvant Completed allowed | Adjuvant Chemotherapy Completed allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1883256
UMLS CUI [2,2]
C1328504
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C0205197
UMLS CUI [3,4]
C0683607
UMLS CUI [4,1]
C0085533
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0683607
prior ketoconazole, aminoglutethimide or corticosteroids for the treatment of progressive prostate cancer.
Beskrivning

Ketoconazole Prostate carcinoma Progressive | Aminoglutethimide Prostate carcinoma Progressive | Adrenal Cortex Hormones Prostate carcinoma Progressive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0205329
UMLS CUI [2,1]
C0002555
UMLS CUI [2,2]
C0600139
UMLS CUI [2,3]
C0205329
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0600139
UMLS CUI [3,3]
C0205329
prior immunotherapy including, but not limited to, vaccines, thalidomide, and or lenalidomide like agents.
Beskrivning

Prior Immunotherapy | Vaccines | Thalidomide | lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1]
C1514461
UMLS CUI [2]
C0042210
UMLS CUI [3]
C0039736
UMLS CUI [4]
C1144149
supplements or complementary medicines/botanicals are not permitted while on protocol therapy, except for any combination of the following:
Beskrivning

Supplements | Pharmaceutical Preparations Complementary | Botanicals Complementary

Datatyp

boolean

Alias
UMLS CUI [1]
C0242295
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0936077
UMLS CUI [3,1]
C1456557
UMLS CUI [3,2]
C0936077
conventional multivitamin supplements selenium lycopene soy supplements patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment serious intercurrent infections or non-malignant medical illnesses including autoimmune disorders that are uncontrolled.
Beskrivning

Exception Multivitamin Supplements | Exception Selenium supplement | Exception Lycopene Supplements | Exception Soy Supplements | Illicit medication use To be stopped | Communicable Diseases Serious Uncontrolled | Non-Malignant Illness Uncontrolled | Autoimmune Diseases Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0301532
UMLS CUI [1,3]
C0242295
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0521939
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0065331
UMLS CUI [3,3]
C0242295
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2756587
UMLS CUI [4,3]
C0242295
UMLS CUI [5,1]
C0281875
UMLS CUI [5,2]
C1272691
UMLS CUI [6,1]
C0009450
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C0205318
UMLS CUI [7,1]
C0221423
UMLS CUI [7,2]
C1518371
UMLS CUI [7,3]
C0205318
UMLS CUI [8,1]
C0004364
UMLS CUI [8,2]
C0205318
psychiatric illnesses/social situations that would limit compliance with protocol requirements.
Beskrivning

Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
evidence of cns (brain or leptomeningeal) metastases or large pleural/pericardial effusions.
Beskrivning

CNS metastases | Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges | Pleural effusion Large | Pericardial effusion Large

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220650
UMLS CUI [3]
C1704231
UMLS CUI [4,1]
C0032227
UMLS CUI [4,2]
C0549177
UMLS CUI [5,1]
C0031039
UMLS CUI [5,2]
C0549177
known contraindication to receive ketoconazole or lenalidomide concurrent use of ketoconazole with statin compounds is absolutely contraindicated. thus, patients receiving statin drugs (fluvastatin, atorvastatin, and simvastatin) should discontinue them for at least 7 days before starting ketoconazole.
Beskrivning

Medical contraindication Ketoconazole | Medical contraindication Lenalidomide | Medical contraindication Concurrent use of Ketoconazole Statins | Statins To be stopped | Fluvastatin To be stopped | Atorvastatin To be stopped | Simvastatin To be stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0022625
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1144149
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C4060806
UMLS CUI [3,3]
C0022625
UMLS CUI [3,4]
C0360714
UMLS CUI [4,1]
C0360714
UMLS CUI [4,2]
C1272691
UMLS CUI [5,1]
C0082608
UMLS CUI [5,2]
C1272691
UMLS CUI [6,1]
C0286651
UMLS CUI [6,2]
C1272691
UMLS CUI [7,1]
C0074554
UMLS CUI [7,2]
C1272691
patients taking astemizole, terfenadine, or cisapride, rifampin or isoniazid are not eligible, unless they agreed to completely discontinue those agents. in that case, any of these agents should be discontinued at least 7 days prior to start therapy with ketoconazole.
Beskrivning

Astemizole | Terfenadine | Cisapride | Rifampin | isoniazid | Exception Pharmaceutical Preparations Discontinued

Datatyp

boolean

Alias
UMLS CUI [1]
C0085170
UMLS CUI [2]
C0085173
UMLS CUI [3]
C0072916
UMLS CUI [4]
C0035608
UMLS CUI [5]
C0022209
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C1444662
use of any other experimental drug or therapy within 28 days of baseline. known hypersensitivity to thalidomide or its analogues. any prior use of lenalidomide. known positive for hiv or infectious hepatitis, type a, b or c. disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the breast.
Beskrivning

Experimental drug Other | Experimental Therapy Other | Hypersensitivity Thalidomide | Hypersensitivity Thalidomide Analogue | lenalidomide | HIV Seropositivity | Hepatitis A positive | Hepatitis B positive | Hepatitis C positive | Disease Free of Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of breast Treated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0039736
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0039736
UMLS CUI [4,3]
C0243071
UMLS CUI [5]
C1144149
UMLS CUI [6]
C0019699
UMLS CUI [7]
C1112370
UMLS CUI [8]
C0856706
UMLS CUI [9]
C1112419
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0332296
UMLS CUI [10,3]
C0006826
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0007117
UMLS CUI [11,3]
C1522326
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0553723
UMLS CUI [12,3]
C1522326
UMLS CUI [13,1]
C1705847
UMLS CUI [13,2]
C0348409
UMLS CUI [13,3]
C1522326
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Similar models

Eligibility Prostate Cancer NCT00460031

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Progressive Disease | Status post Antiandrogen therapy
Item
progressive disease after androgen deprivation.
boolean
C1335499 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0279492 (UMLS CUI [2,2])
Exclusion Criteria | Systemic Chemotherapy Hormone refractory prostate cancer | Chemotherapy Neoadjuvant Completed allowed | Adjuvant Chemotherapy Completed allowed
Item
exclusion criteria prior systemic chemotherapy for hormone refractory prostate cancer. prior neoadjuvant and adjuvant chemotherapy are allowed when completed at least 12 months prior to enrollment.
boolean
C0680251 (UMLS CUI [1])
C1883256 (UMLS CUI [2,1])
C1328504 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0683607 (UMLS CUI [3,4])
C0085533 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Ketoconazole Prostate carcinoma Progressive | Aminoglutethimide Prostate carcinoma Progressive | Adrenal Cortex Hormones Prostate carcinoma Progressive
Item
prior ketoconazole, aminoglutethimide or corticosteroids for the treatment of progressive prostate cancer.
boolean
C0022625 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C0002555 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0205329 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
C0205329 (UMLS CUI [3,3])
Prior Immunotherapy | Vaccines | Thalidomide | lenalidomide
Item
prior immunotherapy including, but not limited to, vaccines, thalidomide, and or lenalidomide like agents.
boolean
C1514461 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C1144149 (UMLS CUI [4])
Supplements | Pharmaceutical Preparations Complementary | Botanicals Complementary
Item
supplements or complementary medicines/botanicals are not permitted while on protocol therapy, except for any combination of the following:
boolean
C0242295 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0936077 (UMLS CUI [2,2])
C1456557 (UMLS CUI [3,1])
C0936077 (UMLS CUI [3,2])
Exception Multivitamin Supplements | Exception Selenium supplement | Exception Lycopene Supplements | Exception Soy Supplements | Illicit medication use To be stopped | Communicable Diseases Serious Uncontrolled | Non-Malignant Illness Uncontrolled | Autoimmune Diseases Uncontrolled
Item
conventional multivitamin supplements selenium lycopene soy supplements patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment serious intercurrent infections or non-malignant medical illnesses including autoimmune disorders that are uncontrolled.
boolean
C1705847 (UMLS CUI [1,1])
C0301532 (UMLS CUI [1,2])
C0242295 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0521939 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0065331 (UMLS CUI [3,2])
C0242295 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C2756587 (UMLS CUI [4,2])
C0242295 (UMLS CUI [4,3])
C0281875 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
C0009450 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0205318 (UMLS CUI [6,3])
C0221423 (UMLS CUI [7,1])
C1518371 (UMLS CUI [7,2])
C0205318 (UMLS CUI [7,3])
C0004364 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
psychiatric illnesses/social situations that would limit compliance with protocol requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
CNS metastases | Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges | Pleural effusion Large | Pericardial effusion Large
Item
evidence of cns (brain or leptomeningeal) metastases or large pleural/pericardial effusions.
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C1704231 (UMLS CUI [3])
C0032227 (UMLS CUI [4,1])
C0549177 (UMLS CUI [4,2])
C0031039 (UMLS CUI [5,1])
C0549177 (UMLS CUI [5,2])
Medical contraindication Ketoconazole | Medical contraindication Lenalidomide | Medical contraindication Concurrent use of Ketoconazole Statins | Statins To be stopped | Fluvastatin To be stopped | Atorvastatin To be stopped | Simvastatin To be stopped
Item
known contraindication to receive ketoconazole or lenalidomide concurrent use of ketoconazole with statin compounds is absolutely contraindicated. thus, patients receiving statin drugs (fluvastatin, atorvastatin, and simvastatin) should discontinue them for at least 7 days before starting ketoconazole.
boolean
C1301624 (UMLS CUI [1,1])
C0022625 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1144149 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C4060806 (UMLS CUI [3,2])
C0022625 (UMLS CUI [3,3])
C0360714 (UMLS CUI [3,4])
C0360714 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
C0082608 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
C0286651 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
C0074554 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
Astemizole | Terfenadine | Cisapride | Rifampin | isoniazid | Exception Pharmaceutical Preparations Discontinued
Item
patients taking astemizole, terfenadine, or cisapride, rifampin or isoniazid are not eligible, unless they agreed to completely discontinue those agents. in that case, any of these agents should be discontinued at least 7 days prior to start therapy with ketoconazole.
boolean
C0085170 (UMLS CUI [1])
C0085173 (UMLS CUI [2])
C0072916 (UMLS CUI [3])
C0035608 (UMLS CUI [4])
C0022209 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C1444662 (UMLS CUI [6,3])
Experimental drug Other | Experimental Therapy Other | Hypersensitivity Thalidomide | Hypersensitivity Thalidomide Analogue | lenalidomide | HIV Seropositivity | Hepatitis A positive | Hepatitis B positive | Hepatitis C positive | Disease Free of Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of breast Treated
Item
use of any other experimental drug or therapy within 28 days of baseline. known hypersensitivity to thalidomide or its analogues. any prior use of lenalidomide. known positive for hiv or infectious hepatitis, type a, b or c. disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the breast.
boolean
C0304229 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0039736 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0039736 (UMLS CUI [4,2])
C0243071 (UMLS CUI [4,3])
C1144149 (UMLS CUI [5])
C0019699 (UMLS CUI [6])
C1112370 (UMLS CUI [7])
C0856706 (UMLS CUI [8])
C1112419 (UMLS CUI [9])
C0012634 (UMLS CUI [10,1])
C0332296 (UMLS CUI [10,2])
C0006826 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0007117 (UMLS CUI [11,2])
C1522326 (UMLS CUI [11,3])
C1705847 (UMLS CUI [12,1])
C0553723 (UMLS CUI [12,2])
C1522326 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0348409 (UMLS CUI [13,2])
C1522326 (UMLS CUI [13,3])
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