ID

13787

Description

Prohibitin Targeting Peptide 1 (Fat Zapper); ODM derived from: https://clinicaltrials.gov/show/NCT01262664

Link

https://clinicaltrials.gov/show/NCT01262664

Keywords

Versions (1)
  1. 3/6/16 3/6/16 -
Uploaded on

March 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01262664

English

Eligibility Prostate Cancer NCT01262664

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a bmi defined as obese (i.e. >30 kg/m2). any histologic variant is acceptable other than small cell carcinoma.
Description

prostata carcinoma; bmi

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C1305855
2. have been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trial.
Description

therapy androgen; testosterone

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0002844
UMLS CUI [2]
C0039601
3. patients with castrate resistant prostate cancer (crpc) must have no standard options for therapy. prior to registration on the study, patients with crpc must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial).
Description

ketoconazole; abiraterone; Dexamethasone

Data type

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2]
C0754011
UMLS CUI [3]
C0011777
4. have an ecog performance status 0, 1 or 2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dl (without transfusion or growth factor support)
Description

bone marrow function; Granulocyte count; platelet count; hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0412480
UMLS CUI [2]
C0857490
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
6. have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and ast </= 2x the upper limits of normal
Description

hepatic function; total bilirubin; Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201899
7. have adequate renal function defined as serum creatinine </= 1.5x the upper limit of normal or creatinine clearance >/= 60 ml/min (measured or calculated). in addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. exception: patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting.
Description

renal function; serum creatinine; creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
8. have adequate cardiovascular function as defined by: i) a normal b-type natruetic peptide (bnp) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ecg. if these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (muga) showing an ef of 45% or greater with no more than "mild" diastolic dysfunction and a bnp of < 200 pg/ml to be eligible.
Description

cardiovascular function; bnp; ecg

Data type

boolean

Alias
UMLS CUI [1]
C0578149
UMLS CUI [2]
C1095989
UMLS CUI [3]
C0013798
9. sign the current irb approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. small cell prostate cancer
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
2. infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
Description

Compliance behavior Limited Comorbidity; infection

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2]
C3714514
3. any of the following in previous 6 months: nyha class iii/iv congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ecg or serologic criteria)
Description

nyha class; congestive heart failure; unstable angina; transient ischemic attack; pulmonary embolism

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0007787
UMLS CUI [5]
C0034065
4. significant co-morbidity that could affect the safety or evaluability of participants, specifically including: i) chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. note that this may be better established with home bp readings than with clinic visit results. note further that this is not a criterion related to particular bp results at the time of assessment for eligibility, nor does it apply to acute bp excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. the intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, not to exclude patients who may be hypertensive acutely. there are no absolute criteria for bp readings with respect to eligibility (as determined by treating physician).
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
5. ( # 9 cont'd) (ii) uncontrolled diabetes mellitus, defined as: hgb a1c >8.5%; or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to >300 mg/dl in prior two months--unless clearly iatrogenic and the cause has been eliminated iii) lung disease requiring supplemental oxygen iv) known chronic liver disease causing either fibrosis or synthetic dysfunction v) known hiv infection vi) overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care.
Description

diabetes mellitus; hiv infection; psychosis

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0033975
6. hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. exception: non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility.
Description

hydronephrosis

Data type

boolean

Alias
UMLS CUI [1]
C0020295
7. patients require ongoing therapy with non-steroidal anti-inflammatory drugs (nsaids), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from nsaids from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less).
Description

nsaid vancomycin aminoglycosides

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0042313
UMLS CUI [1,3]
C0002556
8. any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug.
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
9. unwillingness to maintain adequate contraception measures for the entire course of the study
Description

Contraception status

Data type

boolean

Alias
UMLS CUI [1]
C0420837
10. age < 18 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Prostate Cancer NCT01262664

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
prostata carcinoma; bmi
Item
1. have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a bmi defined as obese (i.e. >30 kg/m2). any histologic variant is acceptable other than small cell carcinoma.
boolean
C0600139 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
therapy androgen; testosterone
Item
2. have been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trial.
boolean
C0087111 (UMLS CUI [1,1])
C0002844 (UMLS CUI [1,2])
C0039601 (UMLS CUI [2])
ketoconazole; abiraterone; Dexamethasone
Item
3. patients with castrate resistant prostate cancer (crpc) must have no standard options for therapy. prior to registration on the study, patients with crpc must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial).
boolean
C0022625 (UMLS CUI [1])
C0754011 (UMLS CUI [2])
C0011777 (UMLS CUI [3])
ecog
Item
4. have an ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
bone marrow function; Granulocyte count; platelet count; hemoglobin
Item
5. have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dl (without transfusion or growth factor support)
boolean
C0412480 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
hepatic function; total bilirubin; Aspartate aminotransferase measurement
Item
6. have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and ast </= 2x the upper limits of normal
boolean
C0232741 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
renal function; serum creatinine; creatinine clearance
Item
7. have adequate renal function defined as serum creatinine </= 1.5x the upper limit of normal or creatinine clearance >/= 60 ml/min (measured or calculated). in addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. exception: patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
cardiovascular function; bnp; ecg
Item
8. have adequate cardiovascular function as defined by: i) a normal b-type natruetic peptide (bnp) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ecg. if these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (muga) showing an ef of 45% or greater with no more than "mild" diastolic dysfunction and a bnp of < 200 pg/ml to be eligible.
boolean
C0578149 (UMLS CUI [1])
C1095989 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
informed consent
Item
9. sign the current irb approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prostate carcinoma
Item
1. small cell prostate cancer
boolean
C0600139 (UMLS CUI [1])
Compliance behavior Limited Comorbidity; infection
Item
2. infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C3714514 (UMLS CUI [2])
nyha class; congestive heart failure; unstable angina; transient ischemic attack; pulmonary embolism
Item
3. any of the following in previous 6 months: nyha class iii/iv congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ecg or serologic criteria)
boolean
C1275491 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0034065 (UMLS CUI [5])
Compliance behavior Limited Comorbidity
Item
4. significant co-morbidity that could affect the safety or evaluability of participants, specifically including: i) chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. note that this may be better established with home bp readings than with clinic visit results. note further that this is not a criterion related to particular bp results at the time of assessment for eligibility, nor does it apply to acute bp excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. the intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, not to exclude patients who may be hypertensive acutely. there are no absolute criteria for bp readings with respect to eligibility (as determined by treating physician).
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
diabetes mellitus; hiv infection; psychosis
Item
5. ( # 9 cont'd) (ii) uncontrolled diabetes mellitus, defined as: hgb a1c >8.5%; or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to >300 mg/dl in prior two months--unless clearly iatrogenic and the cause has been eliminated iii) lung disease requiring supplemental oxygen iv) known chronic liver disease causing either fibrosis or synthetic dysfunction v) known hiv infection vi) overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care.
boolean
C0011849 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
hydronephrosis
Item
6. hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. exception: non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility.
boolean
C0020295 (UMLS CUI [1])
nsaid vancomycin aminoglycosides
Item
7. patients require ongoing therapy with non-steroidal anti-inflammatory drugs (nsaids), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from nsaids from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less).
boolean
C0003211 (UMLS CUI [1,1])
C0042313 (UMLS CUI [1,2])
C0002556 (UMLS CUI [1,3])
Compliance behavior Limited Comorbidity
Item
8. any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Contraception status
Item
9. unwillingness to maintain adequate contraception measures for the entire course of the study
boolean
C0420837 (UMLS CUI [1])
age
Item
10. age < 18 years.
boolean
C0001779 (UMLS CUI [1])
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