ID

13603

Description

Study to Assess the Safety, Tolerability, and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00510939

Link

https://clinicaltrials.gov/show/NCT00510939

Keywords

Versions (1)
  1. 2/19/16 2/19/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 19, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00510939

English

Eligibility Acute Myeloid Leukemia NCT00510939

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written informed consent
Description

1. provision of written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. male or female aged >18 years with newly diagnosed acute myeloid leukemia (aml), de novo or secondary, unfit for conventional chemotherapy
Description

2. male or female aged >18 years with newly diagnosed acute myeloid leukemia (aml), de novo or secondary, unfit for conventional chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C1518321
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C3841806
3. male or female with acute myeloid leukemia in first relapse ( > 60 years)
Description

3. male or female with acute myeloid leukemia in first relapse ( > 60 years)

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0035020
UMLS CUI [2]
C0001779
4. who performance status ³ 2, or/and unwillingness to receive conventional chemotherapy
Description

4. who performance status ³ 2, or/and unwillingness to receive conventional chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C0392920
5. negative pregnancy test or evidence of post-menopausal status for female patients.
Description

negative pregnancy test or evidence of post-menopausal status for female patients.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0232970
6. rasgrp1/aptx gene expression ratio calculated at the screening >10 (part b.2 only)
Description

6. rasgrp1/aptx gene expression ratio calculated at the screening >10 (part b.2 only)

Data type

boolean

Alias
UMLS CUI [1]
C1419283
UMLS CUI [2]
C1423885
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. serum bilirubin 2 x> upper limit of normal (uln)
Description

1. serum bilirubin 2 x> upper limit of normal (uln)

Data type

boolean

Alias
UMLS CUI [1]
C1278039
2. aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) >3.5 x uln
Description

2. aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) >3.5 x uln

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
3. serum creatinine ³ 2.5 x uln or 24-hour creatinine clearance £ 60 ml/min (measured or calculated by cockcroft-gault)
Description

3. serum creatinine ³ 2.5 x uln or 24-hour creatinine clearance £ 60 ml/min (measured or calculated by cockcroft-gault)

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
4. patients with aml of fab m3 classification (apl)
Description

4. patients with aml of fab m3 classification (apl)

Data type

boolean

Alias
UMLS CUI [1]
C0023487
5. patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission
Description

5. patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission

Data type

boolean

Alias
UMLS CUI [1]
C0006826
6. any clinically defined central nervous system aml.
Description

6. any clinically defined central nervous system aml.

Data type

boolean

Alias
UMLS CUI [1]
C1332884
UMLS CUI [2]
C0023467
7. participation in an investigational drug study within the 30 days prior to entry
Description

7. participation in an investigational drug study within the 30 days prior to entry

Data type

boolean

Alias
UMLS CUI [1]
C2348568
8. evidence of uncontrolled infection or cns-hemorrhagic
Description

8. evidence of uncontrolled infection or cns-hemorrhagic

Data type

boolean

Alias
UMLS CUI [1]
C0009488
9. patients with documented cases of human immunodeficiency virus (hiv)
Description

9. patients with documented cases of human immunodeficiency virus (hiv)

Data type

boolean

Alias
UMLS CUI [1]
C0019682
10. peripheral neuropathy or neuropathic pain grade > or = 2
Description

10. peripheral neuropathy or neuropathic pain grade > or = 2

Data type

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C0458960
11. has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
Description

11. has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006030
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0024730
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0019134
12. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 7,nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
Description

12. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 7,nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis

Data type

boolean

Alias
UMLS CUI [1]
C0018799
13. rasgrp1/aptx gene expression ratio calculated at the screening <10 (part b.2 only)
Description

13. rasgrp1/aptx gene expression ratio calculated at the screening <10 (part b.2 only)

Data type

boolean

Alias
UMLS CUI [1]
C1419283
UMLS CUI [2]
C1423885
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Similar models

Eligibility Acute Myeloid Leukemia NCT00510939

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
written informed consent
Item
1. provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
age, aml, unfit for conventional chemotherapy
Item
2. male or female aged >18 years with newly diagnosed acute myeloid leukemia (aml), de novo or secondary, unfit for conventional chemotherapy
boolean
C0001779 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C3841806 (UMLS CUI [3,2])
aml in first relapse
Item
3. male or female with acute myeloid leukemia in first relapse ( > 60 years)
boolean
C0023467 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
who performance status
Item
4. who performance status ³ 2, or/and unwillingness to receive conventional chemotherapy
boolean
C1298650 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
negative pregnancy test or evidence of post-menopausal status for female patients.
Item
5. negative pregnancy test or evidence of post-menopausal status for female patients.
boolean
C0032961 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
rasgrp1/aptx gene expression ratio
Item
6. rasgrp1/aptx gene expression ratio calculated at the screening >10 (part b.2 only)
boolean
C1419283 (UMLS CUI [1])
C1423885 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
serum bilirubin
Item
1. serum bilirubin 2 x> upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
ast and alt
Item
2. aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt) >3.5 x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
creatinine and creatinine clearance
Item
3. serum creatinine ³ 2.5 x uln or 24-hour creatinine clearance £ 60 ml/min (measured or calculated by cockcroft-gault)
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
apl
Item
4. patients with aml of fab m3 classification (apl)
boolean
C0023487 (UMLS CUI [1])
malignancy
Item
5. patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission
boolean
C0006826 (UMLS CUI [1])
central nervous system aml
Item
6. any clinically defined central nervous system aml.
boolean
C1332884 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
participation status
Item
7. participation in an investigational drug study within the 30 days prior to entry
boolean
C2348568 (UMLS CUI [1])
uncontrolled infection or cns-hemorrhagic
Item
8. evidence of uncontrolled infection or cns-hemorrhagic
boolean
C0009488 (UMLS CUI [1])
hiv
Item
9. patients with documented cases of human immunodeficiency virus (hiv)
boolean
C0019682 (UMLS CUI [1])
peripheral neuropathy or neuropathic pain
Item
10. peripheral neuropathy or neuropathic pain grade > or = 2
boolean
C0031117 (UMLS CUI [1])
C0458960 (UMLS CUI [2])
hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
Item
11. has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
boolean
C0020517 (UMLS CUI [1,1])
C0006030 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0024730 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0019134 (UMLS CUI [3,2])
cardiac disease
Item
12. uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, new york heart association (nyha) class iii or iv heart failure (attachment 7,nyha classification of cardiac disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
boolean
C0018799 (UMLS CUI [1])
rasgrp1/aptx gene expression ratio
Item
13. rasgrp1/aptx gene expression ratio calculated at the screening <10 (part b.2 only)
boolean
C1419283 (UMLS CUI [1])
C1423885 (UMLS CUI [2])
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