ID

36849

Description

A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC; ODM derived from: https://clinicaltrials.gov/show/NCT02378870

Link

https://clinicaltrials.gov/show/NCT02378870

Keywords

Versions (1)
  1. 6/16/19 6/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer Metastatic NCT02378870

English

Eligibility Prostate Cancer Metastatic NCT02378870

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥18 years at the time of signing the informed consent form.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
3. failing or not tolerating docetaxel therapy or for other reasons not suitable for such therapy and failing subsequent therapy with abiraterone and/or enzalutamide.
Description

Docetaxel failed | Intolerance to Docetaxel | Abiraterone failed | Enzalutamide failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0246415
UMLS CUI [3,1]
C0754011
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C3496793
UMLS CUI [4,2]
C0231175
4. evidence of metastatic disease from bone scan (bone lesions) or other imaging modality.
Description

Neoplasm Metastasis Bone scan | Bone lesion | Neoplasm Metastasis Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0203668
UMLS CUI [2]
C0238792
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0079595
5. evidence of psa progression in two consecutive determinations at minimum 1 week interval.
Description

Raised prostate specific antigen Determination Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0521095
UMLS CUI [1,3]
C1265611
6. castrate level of serum testosterone ≤1.7 nmol/l
Description

Castration Levels of Testosterone Serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C4289828
UMLS CUI [1,2]
C0428413
7. performance status ecog 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. laboratory requirements: haematology: neutrophils ≥ 1.5 x 109/l hemoglobin ≥ 90 g/l platelets ≥ 100 x 109/l hepatic function: total s-bilirubin ≤ 1.5 times the upper limit of normal (uln) ast (sgot) / alt (sgpt) ≤ 2.5 times uln renal function: s-creatinine ≤ 1.5 times the upper limit of normal (uln) electrolytes: s-sodium, s-potassium, s-calcium (s-albumin corrected), s-phosphate, s-magnesium, all within normal ranges.
Description

Laboratory Requirement | Hematology | Neutrophil count | Hemoglobin measurement | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Electrolytes | Serum sodium level normal | Serum potassium normal | Serum calcium normal | Calcium/albumin Normal | Serum phosphate level normal | Serum magnesium normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C1514873
UMLS CUI [2]
C0200627
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0232741
UMLS CUI [7]
C1278039
UMLS CUI [8]
C0201899
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0232804
UMLS CUI [11]
C0201976
UMLS CUI [12]
C0013832
UMLS CUI [13]
C0580480
UMLS CUI [14]
C0858161
UMLS CUI [15]
C0858094
UMLS CUI [16,1]
C0553061
UMLS CUI [16,2]
C0205307
UMLS CUI [17]
C0580488
UMLS CUI [18]
C0858145
9. no evidence (≤ 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
Description

Malignant Neoplasms Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
10. able to adhere to the study visit schedule and other protocol requirements.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
11. life expectancy ≥6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of lhrh agonist/antagonist or polyestradiol phosphate bicalutamide. washout period bicalutamide 6 weeks; after flutamide 4 weeks; abiraterone / enzalutamide 6 weeks.
Description

Antineoplastic Agents | Cancer treatment | Exception LHRH Agonist Dose Stable | Exception LHRH antagonist Dose Stable | Exception Polyestradiol phosphate Dose Stable | Exception Bicalutamide Dose Stable | Washout Period Bicalutamide | Washout Period Flutamide | Washout Period Abiraterone | Washout Period Enzalutamide

Data type

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1518041
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1276926
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0205360
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0071554
UMLS CUI [5,3]
C0178602
UMLS CUI [5,4]
C0205360
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0285590
UMLS CUI [6,3]
C0178602
UMLS CUI [6,4]
C0205360
UMLS CUI [7,1]
C1710661
UMLS CUI [7,2]
C0285590
UMLS CUI [8,1]
C1710661
UMLS CUI [8,2]
C0016384
UMLS CUI [9,1]
C1710661
UMLS CUI [9,2]
C0754011
UMLS CUI [10,1]
C1710661
UMLS CUI [10,2]
C3496793
2. any treatment modalities involving chemotherapy, radiation or major surgery within 4 weeks prior to treatment in this study.
Description

Chemotherapy | Therapeutic radiology procedure | Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0679637
3. simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
4. any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
Description

Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data | Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0459471
UMLS CUI [1,4]
C0681873
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0681873
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
5. plasma glucose level ≥7 mmol/l (or >120 mg/dl) at screening.
Description

Plasma Glucose Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202042
6. known brain metastases.
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
7. dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug.
Description

Dental surgical procedure | Tooth Extraction | Periodontal Disease | Trauma Local | Denture unstable

Data type

boolean

Alias
UMLS CUI [1]
C0204324
UMLS CUI [2]
C0040440
UMLS CUI [3]
C0031090
UMLS CUI [4,1]
C1301685
UMLS CUI [4,2]
C0205276
UMLS CUI [5]
C0457728
8. treatment with bisphosphonates within 4 weeks prior to first dose of study medication.
Description

Diphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0012544
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Similar models

Eligibility Prostate Cancer Metastatic NCT02378870

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥18 years at the time of signing the informed consent form.
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
2. histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Docetaxel failed | Intolerance to Docetaxel | Abiraterone failed | Enzalutamide failed
Item
3. failing or not tolerating docetaxel therapy or for other reasons not suitable for such therapy and failing subsequent therapy with abiraterone and/or enzalutamide.
boolean
C0246415 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C0754011 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C3496793 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
Neoplasm Metastasis Bone scan | Bone lesion | Neoplasm Metastasis Imaging
Item
4. evidence of metastatic disease from bone scan (bone lesions) or other imaging modality.
boolean
C0027627 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C0079595 (UMLS CUI [3,2])
Raised prostate specific antigen Determination Quantity
Item
5. evidence of psa progression in two consecutive determinations at minimum 1 week interval.
boolean
C0178415 (UMLS CUI [1,1])
C0521095 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Castration Levels of Testosterone Serum testosterone measurement
Item
6. castrate level of serum testosterone ≤1.7 nmol/l
boolean
C4289828 (UMLS CUI [1,1])
C0428413 (UMLS CUI [1,2])
ECOG performance status
Item
7. performance status ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Laboratory Requirement | Hematology | Neutrophil count | Hemoglobin measurement | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum | Electrolytes | Serum sodium level normal | Serum potassium normal | Serum calcium normal | Calcium/albumin Normal | Serum phosphate level normal | Serum magnesium normal
Item
8. laboratory requirements: haematology: neutrophils ≥ 1.5 x 109/l hemoglobin ≥ 90 g/l platelets ≥ 100 x 109/l hepatic function: total s-bilirubin ≤ 1.5 times the upper limit of normal (uln) ast (sgot) / alt (sgpt) ≤ 2.5 times uln renal function: s-creatinine ≤ 1.5 times the upper limit of normal (uln) electrolytes: s-sodium, s-potassium, s-calcium (s-albumin corrected), s-phosphate, s-magnesium, all within normal ranges.
boolean
C0022877 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0200627 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0232741 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C0201899 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0232804 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
C0013832 (UMLS CUI [12])
C0580480 (UMLS CUI [13])
C0858161 (UMLS CUI [14])
C0858094 (UMLS CUI [15])
C0553061 (UMLS CUI [16,1])
C0205307 (UMLS CUI [16,2])
C0580488 (UMLS CUI [17])
C0858145 (UMLS CUI [18])
Malignant Neoplasms Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
9. no evidence (≤ 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Protocol Compliance
Item
10. able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Life Expectancy
Item
11. life expectancy ≥6 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antineoplastic Agents | Cancer treatment | Exception LHRH Agonist Dose Stable | Exception LHRH antagonist Dose Stable | Exception Polyestradiol phosphate Dose Stable | Exception Bicalutamide Dose Stable | Washout Period Bicalutamide | Washout Period Flutamide | Washout Period Abiraterone | Washout Period Enzalutamide
Item
1. concurrent use of other anti-cancer agents or treatments, with the following exception: a stable dose of lhrh agonist/antagonist or polyestradiol phosphate bicalutamide. washout period bicalutamide 6 weeks; after flutamide 4 weeks; abiraterone / enzalutamide 6 weeks.
boolean
C0003392 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1518041 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1276926 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0205360 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0071554 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0285590 (UMLS CUI [6,2])
C0178602 (UMLS CUI [6,3])
C0205360 (UMLS CUI [6,4])
C1710661 (UMLS CUI [7,1])
C0285590 (UMLS CUI [7,2])
C1710661 (UMLS CUI [8,1])
C0016384 (UMLS CUI [8,2])
C1710661 (UMLS CUI [9,1])
C0754011 (UMLS CUI [9,2])
C1710661 (UMLS CUI [10,1])
C3496793 (UMLS CUI [10,2])
Chemotherapy | Therapeutic radiology procedure | Major surgery
Item
2. any treatment modalities involving chemotherapy, radiation or major surgery within 4 weeks prior to treatment in this study.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
3. simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Condition Interferes with Interpretation Research data | Laboratory test result abnormal Interferes with Interpretation Research data | Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk
Item
4. any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0681873 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
Plasma Glucose Measurement
Item
5. plasma glucose level ≥7 mmol/l (or >120 mg/dl) at screening.
boolean
C0202042 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
6. known brain metastases.
boolean
C0220650 (UMLS CUI [1])
Dental surgical procedure | Tooth Extraction | Periodontal Disease | Trauma Local | Denture unstable
Item
7. dental surgery (dental extraction), periodontal disease, local trauma including poorly fitting dentures within 6 months prior to the first dose of study drug.
boolean
C0204324 (UMLS CUI [1])
C0040440 (UMLS CUI [2])
C0031090 (UMLS CUI [3])
C1301685 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C0457728 (UMLS CUI [5])
Diphosphonates
Item
8. treatment with bisphosphonates within 4 weeks prior to first dose of study medication.
boolean
C0012544 (UMLS CUI [1])
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