ID

12543

Beskrivning

AZD6738 First Time in Patient Multiple Ascending Dose Study; ODM derived from: https://clinicaltrials.gov/show/NCT01955668

Länk

https://clinicaltrials.gov/show/NCT01955668

Nyckelord

Versioner (1)
  1. 2015-11-27 2015-11-27 -
Uppladdad den

27 november 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility 11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL), NCT01955668

Engelsk

Eligibility 11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL), NCT01955668

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
Signed informed consent
Beskrivning

provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
b cell malignancy
Beskrivning

for the dose escalation phase, part a, histological or cytological confirmation of relapsed or refractory b cell malignancy, including cll, pll, burkitt lymphoma/burkitt cell leukaemia, acute lymphocytic leukaemia, hairy cell leukaemia (hcl) and aggressive and indolent b cell lymphoma, not considered to be appropriate for further conventional treatment.

Datatyp

boolean

Alias
UMLS CUI [1]
C0023449
refractory cll
Beskrivning

for the dose expansion phase, part b, histological or cytological confirmation of relapsed or refractory 11q-deleted or atm-deficient cll, not considered to be appropriate for further conventional treatment.

Datatyp

boolean

Alias
UMLS CUI [1]
C0278791
Performance status (ECOG):
Beskrivning

eastern cooperative oncology group (ecog) performance status 0 or 1 with no deterioration over the previous 2 weeks and an estimated life expectancy of greater than 16 weeks.

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Not positive with Communicable diseases
Beskrivning

not known to be positive for hiv antibody, hepatitis b surface antigen and hepatitis c antibody.

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019683
UMLS CUI [3]
C0019165
UMLS CUI [4]
C0166049
females of childbearing potential must be using adequate contraceptive measures and not be breastfeeding
Beskrivning

females must be using adequate contraceptive measures, must not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening

Datatyp

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0006147
Postmenopausal
Beskrivning

post menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
irreversible surgical sterilisation
Beskrivning

documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation

Datatyp

boolean

Alias
UMLS CUI [1]
C0015787
Hormone levels in postmenopausal range and amenorrhoeic for 12 months
Beskrivning

amenorrhoeic for 12 months and serum follicle-stimulating hormone (fsh), luteinizing hormone (lh) and plasma oestradiol levels in the postmenopausal range for the institution.

Datatyp

boolean

Alias
UMLS CUI [1]
C0002453
UMLS CUI [2]
C2229715
UMLS CUI [3]
C2229812
UMLS CUI [4]
C1295644
ability to swallow and retain oral medication
Beskrivning

ability to swallow and retain oral medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0175795
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
cancer treatment during 4 weeks prior to study entry
Beskrivning

receiving, or having received during the four weeks prior to study entry (signing of consent), treatment for their malignancy.

Datatyp

boolean

Alias
UMLS CUI [1]
C0920425
Concomitant Medication with corticosteroids
Beskrivning

receiving, or having received during the four weeks prior to study entry (signing of consent), corticosteroids (at a dose > 10 mg prednisone/day or equivalent) for any reason.

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0001617
Hypersensitivity to the trial drug or the excipients
Beskrivning

a known hypersensitivity to azd6738 or any excipient of the product

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C3827158
Subject Participation Status in Clinical Study within 28 days prior to IC
Beskrivning

treatment with any investigational medicinal product (imp) within 28 days prior to signing of consent

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Concomitant Medication modulating cyp3a4 or pgp activity
Beskrivning

receiving, or having received, concomitant medications, herbal supplements and/or foods that significantly modulate cyp3a4 or pgp activity (wash out periods of two weeks, but three weeks for st. john's wort). note these include common azole antifungals, macrolide antibiotics

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C1142644
UMLS CUI [3]
C1149921
impaired hepatic function
Beskrivning

impaired hepatic function as demonstrated by any of the following laboratory values

Datatyp

text

Alias
UMLS CUI [1]
C0086565
Impaired renal function
Beskrivning

glomerular filtration rate (gfr) < 50 ml/min, as assessed using the standard methodology at the investigating centre (i.e. cockroft-gault, mdrd or ckd-epi formulae, edta clearance or 24 h urine collection)

Datatyp

text

Alias
UMLS CUI [1]
C0151746
Unstable or worsening liver or renal dysfunction
Beskrivning

ast, alt, alp, bilirubin or renal function that, in the opinion of the investigator, is unstable or worsening

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
inr > 1.5 or other evidence of impaired hepatic synthesis function
Beskrivning

inr > 1.5 or other evidence of impaired hepatic synthesis function persisting (> 8 weeks) severe pancytopenia due to previous therapy rather than disease (anc < 0.5 x 109/l or platelets < 50 x 109/l) - to be confirmed via bone marrow biopsy, as part of normal clinical care, prior to signing of consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0853225
UMLS CUI [2]
C0086565
cns involvement with malignancy
Beskrivning

cns involvement with malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0449389
cardiac dysfunction
Beskrivning

cardiac dysfunction as defined as: myocardial infarction within six months of study entry, nyha class ii/iii/iv heart failure, unstable angina, unstable cardiac arrhythmias or reduced lvef < 55%

Datatyp

text

Alias
UMLS CUI [1]
C3277906
any of the following cardiac criteria
Beskrivning

any of the following cardiac criteria

Datatyp

text

Alias
UMLS CUI [1]
C0855333
UMLS CUI [2]
C0023211
UMLS CUI [3]
C0151517
risk of qtc prolongation or risk of arrhythmic events
Beskrivning

any factors that increase the risk of qtc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long qt syndrome, immediate family history of long qt syndrome or unexplained sudden death under 40 years of age

Datatyp

boolean

Alias
UMLS CUI [1]
C0855333
UMLS CUI [2]
C0003811
patients at risk of brain perfusion problems
Beskrivning

e.g., carotid stenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0007282
hypotension
Beskrivning

patients with relative hypotension (< 100/60 mm/hg) or clinically relevant orthostatic hypotension, including a fall in blood pressure of >20mm/hg

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0020649
uncontrolled hypertension
Beskrivning

uncontrolled hypertension requiring clinical intervention

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0020538
any other malignancy which has been active or treated within the past three years, with the exception of cervical intra-epithelial neoplasia and non-melanoma skin cancer
Beskrivning

any other malignancy which has been active or treated within the past three years, with the exception of cervical intra-epithelial neoplasia and non-melanoma skin cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0006826
Comorbidity that would preclude adequate absorption of azd6738
Beskrivning

refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0027497
UMLS CUI [3]
C0042963
UMLS CUI [4]
C0017178
patients with uncontrolled seizures
Beskrivning

patients with uncontrolled seizures

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0014544
active infection requiring systemic antibiotics, antifungal or antiviral drugs
Beskrivning

active infection requiring systemic antibiotics, antifungal or antiviral drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0009450
concurrent severe and/or uncontrolled medical condition (e.g., severe copd, severe parkinson's disease, active inflammatory bowel disease) or psychiatric condition
Beskrivning

(e.g., severe copd, severe parkinson's disease, active inflammatory bowel disease)

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility 11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL), NCT01955668

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Signed informed consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI [1])
b cell malignancy
Item
b cell malignancy
boolean
C0023449 (UMLS CUI [1])
refractory cll
Item
refractory cll
boolean
C0278791 (UMLS CUI [1])
ECOG
Item
Performance status (ECOG):
boolean
C1520224 (UMLS CUI [1])
Not positive with Communicable diseases
Item
Not positive with Communicable diseases
boolean
C0009450 (UMLS CUI [1])
C0019683 (UMLS CUI [2])
C0019165 (UMLS CUI [3])
C0166049 (UMLS CUI [4])
females of childbearing potential must be using adequate contraceptive measures and not be breastfeeding
Item
females of childbearing potential must be using adequate contraceptive measures and not be breastfeeding
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Postmenopausal
Item
Postmenopausal
boolean
C0232970 (UMLS CUI [1])
irreversible surgical sterilisation
Item
irreversible surgical sterilisation
boolean
C0015787 (UMLS CUI [1])
Hormone levels in postmenopausal range and amenorrhoeic for 12 months
Item
Hormone levels in postmenopausal range and amenorrhoeic for 12 months
boolean
C0002453 (UMLS CUI [1])
C2229715 (UMLS CUI [2])
C2229812 (UMLS CUI [3])
C1295644 (UMLS CUI [4])
ability to swallow and retain oral medication
Item
ability to swallow and retain oral medication
boolean
C0175795 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cancer treatment during 4 weeks prior to study entry
Item
cancer treatment during 4 weeks prior to study entry
boolean
C0920425 (UMLS CUI [1])
Concomitant Medication with corticosteroids
Item
Concomitant Medication with corticosteroids
boolean
C2347852 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
Hypersensitivity to the trial drug or the excipients
Item
Hypersensitivity to the trial drug or the excipients
boolean
C0020517 (UMLS CUI [1])
C3827158 (UMLS CUI [2])
Study Subject Participation Status
Item
Subject Participation Status in Clinical Study within 28 days prior to IC
boolean
C2348568 (UMLS CUI [1])
Concomitant Medication modulating cyp3a4 or pgp activity
Item
Concomitant Medication modulating cyp3a4 or pgp activity
boolean
C2347852 (UMLS CUI [1])
C1142644 (UMLS CUI [2])
C1149921 (UMLS CUI [3])
Item
impaired hepatic function
text
C0086565 (UMLS CUI [1])
impaired hepatic function
Code List
impaired hepatic function
CL Item
albumin < 33g/l (1)
CL Item
ast or alt > 2.5 x uln (2)
CL Item
total bilirubin > 1.5 x uln (3)
CL Item
alkaline phosphatase > 2.5 x uln (4)
Item
Impaired renal function
text
C0151746 (UMLS CUI [1])
Impaired renal function
Code List
Impaired renal function
CL Item
glomerular filtration rate (gfr) < 50 ml/min (1)
CL Item
serum creatinine > 1.5 x uln  (2)
CL Item
haematuria: +++ on microscopy or dipstick (3)
Unstable or worsening liver or renal dysfunction
Item
Unstable or worsening liver or renal dysfunction
boolean
C0009488 (UMLS CUI [1])
inr higher 1.5 or other evidence of impaired hepatic synthesis function
Item
inr > 1.5 or other evidence of impaired hepatic synthesis function
boolean
C0853225 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
cns involvement with malignancy
Item
cns involvement with malignancy
boolean
C0449389 (UMLS CUI [1])
Item
cardiac dysfunction
text
C3277906 (UMLS CUI [1])
cardiac dysfunction
Code List
cardiac dysfunction
CL Item
myocardial infarction (1)
CL Item
nyha class ii/iii/iv heart failure (2)
CL Item
unstable angina (3)
CL Item
unstable cardiac arrhythmias (4)
CL Item
reduced lvef < 55% (5)
Item
any of the following cardiac criteria
text
C0855333 (UMLS CUI [1])
C0023211 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
any of the following cardiac criteria
Code List
any of the following cardiac criteria
CL Item
mean resting corrected qt interval (qtc) >470 msec obtained from 3 electrocardiograms (ecgs) in 24 hours (1)
CL Item
any clinically important abnormalities in rhythm (2)
CL Item
any clinically important abnormalities in conduction (3)
CL Item
any clinically important abnormalities in morphology (4)
risk of qtc prolongation or risk of arrhythmic events
Item
risk of qtc prolongation or risk of arrhythmic events
boolean
C0855333 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
patients at risk of brain perfusion problems
Item
patients at risk of brain perfusion problems
boolean
C0009488 (UMLS CUI [1])
C0007282 (UMLS CUI [2])
hypotension
Item
hypotension
boolean
C0009488 (UMLS CUI [1])
C0020649 (UMLS CUI [2])
uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C0009488 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
any other malignancy which has been active or treated within the past three years, with the exception of cervical intra-epithelial neoplasia and non-melanoma skin cancer
Item
any other malignancy which has been active or treated within the past three years, with the exception of cervical intra-epithelial neoplasia and non-melanoma skin cancer
boolean
C0009488 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Comorbidity that would preclude adequate absorption of azd6738
Item
Comorbidity that would preclude adequate absorption of azd6738
boolean
C0009488 (UMLS CUI [1])
C0027497 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
patients with uncontrolled seizures
Item
patients with uncontrolled seizures
boolean
C0009488 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
active infection requiring systemic antibiotics, antifungal or antiviral drugs
Item
active infection requiring systemic antibiotics, antifungal or antiviral drugs
boolean
C0009488 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
concurrent severe and or uncontrolled medical condition or psychiatric condition
Item
concurrent severe and/or uncontrolled medical condition (e.g., severe copd, severe parkinson's disease, active inflammatory bowel disease) or psychiatric condition
boolean
C0009488 (UMLS CUI [1])
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