ID

31556

Beschreibung

A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00564928

Link

https://clinicaltrials.gov/show/NCT00564928

Stichworte

Versionen (1)
  1. 04.09.18 04.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. September 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00564928

Englisch

Eligibility Prostate Cancer NCT00564928

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
resolution of acute toxic side effects of prior chemotherapy
Beschreibung

Prior Chemotherapy | Resolution Side effects Toxic

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C1514893
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C1407029
castration resistant disease despite ongoing chemical or surgical castration
Beschreibung

Disease Resistant to Castration | Chemical male castration | Male Castration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0007347
UMLS CUI [2]
C0455189
UMLS CUI [3]
C0007347
ecog 0-1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
psa greater than or equal to 2
Beschreibung

Prostate specific antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
group a -
Beschreibung

Group Roman letter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0439102
no prior treatment for prostate cancer with cytotoxic chemotherapy (neoadjuvant, adjuvant treatment permitted if more than 2 years out)
Beschreibung

Cytotoxic Chemotherapy Absent Prostate carcinoma | Neoadjuvant Therapy allowed | Adjuvant therapy allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0677850
UMLS CUI [3,2]
C0683607
group b
Beschreibung

Group Roman letter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C0439102
radiographic evidence of metastatic disease
Beschreibung

Neoplasm Metastasis Radiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0034571
prior tx with docetaxel-minimum of 2 cycles with progression by recist or psa or intolerant of tx
Beschreibung

Docetaxel Course Quantity Minimum | Disease Progression Prostate specific antigen measurement | Intolerance Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1524031
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0201544
UMLS CUI [3,1]
C0231199
UMLS CUI [3,2]
C0087111
maximum of 3 prior chemotherapies
Beschreibung

Prior Chemotherapy Quantity Maximum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0806909
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
small cell carcinoma of the prostate
Beschreibung

Small cell carcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C1300585
treatment within 2 weeks with approved, investigational, or small molecule
Beschreibung

Molecule Treatment Approved | Molecule Treatment Investigational | Small Molecule Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0567416
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205540
UMLS CUI [2,1]
C0567416
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1517586
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C0087111
treatment within 4 weeks with biologic or external beam radiation
Beschreibung

Biological treatment | External beam radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1531518
UMLS CUI [2]
C0419095
anc <1,500 cells m3; platelets <100,000 mm3; hemoglobin <9.0g/dl
Beschreibung

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
ast/alt >2.5 uln
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
serum creatinine >3.0mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
active keratitis or keratoconjunctivitis
Beschreibung

Keratitis | Keratoconjunctivitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0022568
UMLS CUI [2]
C0022573
previous treatment with 17-aag, dmag; or any other hsp-90 inhibitor
Beschreibung

17-AAG | 17-DMAG | HSP90 Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0675974
UMLS CUI [2]
C1527262
UMLS CUI [3,1]
C0243044
UMLS CUI [3,2]
C0243077
baseline qtc >450 mses
Beschreibung

Prolonged QTc

Datentyp

boolean

Alias
UMLS CUI [1]
C1969409
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00564928

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Prior Chemotherapy | Resolution Side effects Toxic
Item
resolution of acute toxic side effects of prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
C1514893 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C1407029 (UMLS CUI [2,3])
Disease Resistant to Castration | Chemical male castration | Male Castration
Item
castration resistant disease despite ongoing chemical or surgical castration
boolean
C0012634 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0007347 (UMLS CUI [1,3])
C0455189 (UMLS CUI [2])
C0007347 (UMLS CUI [3])
ECOG performance status
Item
ecog 0-1
boolean
C1520224 (UMLS CUI [1])
Prostate specific antigen measurement
Item
psa greater than or equal to 2
boolean
C0201544 (UMLS CUI [1])
Group Roman letter
Item
group a -
boolean
C0441833 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Cytotoxic Chemotherapy Absent Prostate carcinoma | Neoadjuvant Therapy allowed | Adjuvant therapy allowed
Item
no prior treatment for prostate cancer with cytotoxic chemotherapy (neoadjuvant, adjuvant treatment permitted if more than 2 years out)
boolean
C0677881 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Group Roman letter
Item
group b
boolean
C0441833 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Neoplasm Metastasis Radiography
Item
radiographic evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Docetaxel Course Quantity Minimum | Disease Progression Prostate specific antigen measurement | Intolerance Therapeutic procedure
Item
prior tx with docetaxel-minimum of 2 cycles with progression by recist or psa or intolerant of tx
boolean
C0246415 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1524031 (UMLS CUI [1,4])
C0242656 (UMLS CUI [2,1])
C0201544 (UMLS CUI [2,2])
C0231199 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
Prior Chemotherapy Quantity Maximum
Item
maximum of 3 prior chemotherapies
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Small cell carcinoma of prostate
Item
small cell carcinoma of the prostate
boolean
C1300585 (UMLS CUI [1])
Molecule Treatment Approved | Molecule Treatment Investigational | Small Molecule Treatment
Item
treatment within 2 weeks with approved, investigational, or small molecule
boolean
C0567416 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205540 (UMLS CUI [1,3])
C0567416 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1517586 (UMLS CUI [2,3])
C1328819 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
Biological treatment | External beam radiotherapy
Item
treatment within 4 weeks with biologic or external beam radiation
boolean
C1531518 (UMLS CUI [1])
C0419095 (UMLS CUI [2])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
anc <1,500 cells m3; platelets <100,000 mm3; hemoglobin <9.0g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast/alt >2.5 uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine >3.0mg/dl
boolean
C0201976 (UMLS CUI [1])
Keratitis | Keratoconjunctivitis
Item
active keratitis or keratoconjunctivitis
boolean
C0022568 (UMLS CUI [1])
C0022573 (UMLS CUI [2])
17-AAG | 17-DMAG | HSP90 Inhibitors
Item
previous treatment with 17-aag, dmag; or any other hsp-90 inhibitor
boolean
C0675974 (UMLS CUI [1])
C1527262 (UMLS CUI [2])
C0243044 (UMLS CUI [3,1])
C0243077 (UMLS CUI [3,2])
Prolonged QTc
Item
baseline qtc >450 mses
boolean
C1969409 (UMLS CUI [1])
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