ID

21542

Beschrijving

Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC; ODM derived from: https://clinicaltrials.gov/show/NCT00286793

Link

https://clinicaltrials.gov/show/NCT00286793

Trefwoorden

Versies (1)
  1. 26-04-17 26-04-17 -
Geüploaded op

26 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00286793

Engels

Eligibility Prostate Cancer NCT00286793

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. rising prostate specific antigen (psa) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (lhrh) agonist therapy.
Beschrijving

PSA Level

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
2. patients must have metastatic disease by bone scan, computed tomography (ct) scan, or magnetic resonance imaging (mri).
Beschrijving

Metastatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
3. ecog performance status 0 or 1
Beschrijving

ECOG Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
4. adequate hematologic function
Beschrijving

Hematologic function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
5. adequate liver and renal function
Beschrijving

Liver and renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
6. able to swallow and retain oral medication.
Beschrijving

Swallow ability and retain oral medication

Datatype

boolean

Alias
UMLS CUI [1]
C0566355
UMLS CUI [2,1]
C0566321
UMLS CUI [2,2]
C0175795
7. patients enrolled into cohort b must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising psa, progression of disease per recist, or >2 new lesions on bone scan.
Beschrijving

Disease progression during treatment with docetaxel regimen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0246415
8. patients enrolled into cohort b must have received at least two cycles of docetaxel. minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
Beschrijving

Docetaxel dosage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0178602
9. at least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.
Beschrijving

Prior pharmacotherapy and radiation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0279134
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients enrolled into cohort a must not have received prior chemotherapy for hrpc.
Beschrijving

Chemotherapy for HRPC

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1328504
2. known history of or clinical evidence of central nervous system (cns) metastases.
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
3. active secondary malignancy or history of other malignancy within the last 5 years.
Beschrijving

Secondary or prior malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C3266877
UMLS CUI [2]
C2735088
4. prior history of radiation therapy to > 25% of the bone marrow
Beschrijving

Prior Radiation to bone marrow

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
5. peripheral neuropathy of > grade 2
Beschrijving

Peripheral neuropathy grade

Datatype

boolean

Alias
UMLS CUI [1]
C3869673
6. uncontrolled concurrent illness
Beschrijving

Comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
7. failure to recover fully, as judged by the investigator, from prior surgical procedures.
Beschrijving

Recovery from surgical procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0237820
UMLS CUI [1,2]
C0543467
8. concurrent anti-cancer therapy other than docetaxel and prednisone.
Beschrijving

Concurrent antineoplastic therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C2346834
UMLS CUI [1,2]
C0009429
9. patients must not be receiving concurrent anti-androgen hormonal therapy for hrpc (lhrh therapies are acceptable to maintain castrate levels of testosterone)
Beschrijving

Concurrent anti-androgen hormonal therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0009429
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Similar models

Eligibility Prostate Cancer NCT00286793

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
PSA Level
Item
1. rising prostate specific antigen (psa) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (lhrh) agonist therapy.
boolean
C0201544 (UMLS CUI [1])
Metastatic disease
Item
2. patients must have metastatic disease by bone scan, computed tomography (ct) scan, or magnetic resonance imaging (mri).
boolean
C0027627 (UMLS CUI [1])
ECOG Performance Status
Item
3. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
4. adequate hematologic function
boolean
C0221130 (UMLS CUI [1])
Liver and renal function
Item
5. adequate liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Swallow ability and retain oral medication
Item
6. able to swallow and retain oral medication.
boolean
C0566355 (UMLS CUI [1])
C0566321 (UMLS CUI [2,1])
C0175795 (UMLS CUI [2,2])
Disease progression during treatment with docetaxel regimen
Item
7. patients enrolled into cohort b must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising psa, progression of disease per recist, or >2 new lesions on bone scan.
boolean
C0242656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
Docetaxel dosage
Item
8. patients enrolled into cohort b must have received at least two cycles of docetaxel. minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
boolean
C0246415 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Prior pharmacotherapy and radiation
Item
9. at least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.
boolean
C0013216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy for HRPC
Item
1. patients enrolled into cohort a must not have received prior chemotherapy for hrpc.
boolean
C0392920 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
CNS metastases
Item
2. known history of or clinical evidence of central nervous system (cns) metastases.
boolean
C0686377 (UMLS CUI [1])
Secondary or prior malignancy
Item
3. active secondary malignancy or history of other malignancy within the last 5 years.
boolean
C3266877 (UMLS CUI [1])
C2735088 (UMLS CUI [2])
Prior Radiation to bone marrow
Item
4. prior history of radiation therapy to > 25% of the bone marrow
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Peripheral neuropathy grade
Item
5. peripheral neuropathy of > grade 2
boolean
C3869673 (UMLS CUI [1])
Comorbidity
Item
6. uncontrolled concurrent illness
boolean
C0009488 (UMLS CUI [1])
Recovery from surgical procedures
Item
7. failure to recover fully, as judged by the investigator, from prior surgical procedures.
boolean
C0237820 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Concurrent antineoplastic therapy
Item
8. concurrent anti-cancer therapy other than docetaxel and prednisone.
boolean
C2346834 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
Concurrent anti-androgen hormonal therapy
Item
9. patients must not be receiving concurrent anti-androgen hormonal therapy for hrpc (lhrh therapies are acceptable to maintain castrate levels of testosterone)
boolean
C0279492 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
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