ID

43983

Description

Extension Study of the Safety and Efficacy of Atiprimod Treatment in Neuroendocrine Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00663429

Link

https://clinicaltrials.gov/show/NCT00663429

Keywords

Versions (2)
  1. 7/4/17 7/4/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Neuroendocrine Carcinoma NCT00663429

English

Eligibility Neuroendocrine Carcinoma NCT00663429

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject was enrolled in protocol no. cp-106 and successfully completed 12 treatment cycles.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0008976
2. subject must have been classified as a responder at the time of completion of protocol no. cp-106 [i.e., sd or better per recist committee criteria or stable symptoms or better (defined as an average daily frequency of bowel movements, flushing episodes and/or wheezing episodes that is the same as or less than the average daily frequency of bowel movements, flushing episodes and/or wheezing episodes recorded during the 14-day screening period prior to enrollment in protocol no. cp-106)].
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1,1]
C0012240
UMLS CUI [1,2]
C0919876
3. subject must understand and voluntarily sign the informed consent document.
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0021430
4. subject must have adequate organ function defined as follows: absolute granulocyte count (agc) >1,500/mm3, hemoglobin >8 g/dl, platelets >100,000/mm3, serum bilirubin <1.5 x upper limit of normal (uln), serum creatinine <1.5 mg/dl, sgot ≤grade 1 per nci ctcae, sgpt ≤grade 1 per nci ctcae.
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0678852
5. women of child bearing potential (wcbp) must have a negative serum or urine pregnancy test. in addition sexually active wcbp must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0009862
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject who was enrolled in protocol no. cp-106 and who did not successfully complete 12 treatment cycles.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0008976
2. if wcbp, pregnant, lactating or not using adequate contraception.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0009862
3. clinically relevant active infection or serious co-morbid medical conditions that are uncontrolled or whose control may be jeopardized by atiprimod treatment.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0012634
4. psychiatric disorders rendering subjects incapable of complying with the requirements of the protocol.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
5. any condition which, in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0012634
6. as atiprimod is a potent inhibitor of cyp2d6, the use of drugs that are substrates of cyp2d6 (e.g. beta blockers, antidepressants, and antipsychotic;) will not be allowed while on study.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1,1]
C0057223
UMLS CUI [1,2]
C1579206
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Similar models

Eligibility Neuroendocrine Carcinoma NCT00663429

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
1. subject was enrolled in protocol no. cp-106 and successfully completed 12 treatment cycles.
boolean
C0087111 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
ID.2
Item
2. subject must have been classified as a responder at the time of completion of protocol no. cp-106 [i.e., sd or better per recist committee criteria or stable symptoms or better (defined as an average daily frequency of bowel movements, flushing episodes and/or wheezing episodes that is the same as or less than the average daily frequency of bowel movements, flushing episodes and/or wheezing episodes recorded during the 14-day screening period prior to enrollment in protocol no. cp-106)].
boolean
C0012240 (UMLS CUI [1,1])
C0919876 (UMLS CUI [1,2])
ID.3
Item
3. subject must understand and voluntarily sign the informed consent document.
boolean
C0021430 (UMLS CUI [1])
ID.4
Item
4. subject must have adequate organ function defined as follows: absolute granulocyte count (agc) >1,500/mm3, hemoglobin >8 g/dl, platelets >100,000/mm3, serum bilirubin <1.5 x upper limit of normal (uln), serum creatinine <1.5 mg/dl, sgot ≤grade 1 per nci ctcae, sgpt ≤grade 1 per nci ctcae.
boolean
C0678852 (UMLS CUI [1])
ID.5
Item
5. women of child bearing potential (wcbp) must have a negative serum or urine pregnancy test. in addition sexually active wcbp must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).
boolean
C0032961 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
1. subject who was enrolled in protocol no. cp-106 and who did not successfully complete 12 treatment cycles.
boolean
C0087111 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
ID.7
Item
2. if wcbp, pregnant, lactating or not using adequate contraception.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,3])
ID.8
Item
3. clinically relevant active infection or serious co-morbid medical conditions that are uncontrolled or whose control may be jeopardized by atiprimod treatment.
boolean
C3714514 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
ID.9
Item
4. psychiatric disorders rendering subjects incapable of complying with the requirements of the protocol.
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
ID.10
Item
5. any condition which, in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
boolean
C0012634 (UMLS CUI [1])
ID.11
Item
6. as atiprimod is a potent inhibitor of cyp2d6, the use of drugs that are substrates of cyp2d6 (e.g. beta blockers, antidepressants, and antipsychotic;) will not be allowed while on study.
boolean
C0057223 (UMLS CUI [1,1])
C1579206 (UMLS CUI [1,2])
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