ID

36074

Description

Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01948843

Link

https://clinicaltrials.gov/show/NCT01948843

Keywords

Versions (1)
  1. 4/14/19 4/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility HER2 Negative Metastatic Breast Cancer NCT01948843

English

Eligibility HER2 Negative Metastatic Breast Cancer NCT01948843

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. biopsy proven her2 negative metastatic breast cancer (dose escalation portion and mtd expansion portion) or advanced solid tumor (dose escalation portion).
Description

Secondary malignant neoplasm of female breast HER2 Negative | Dose Escalation | Maximum Tolerated Dose | Advanced solid tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C2348908
UMLS CUI [2]
C3816728
UMLS CUI [3]
C0752079
UMLS CUI [4]
C4329281
2. ass deficiency (defined as <50% ass expression) demonstrated on tissue specimen by immunohistochemistry (ihc). cytology and fine need aspirate specimens are not acceptable for ass testing.
Description

ASS deficiency | Tissue specimen Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1]
C0175683
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C0021044
3. unresectable disease or subject refused surgery.
Description

Disease unresectable | Study Subject Refused Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0749192
4. measurable disease as assessed by recist 1.1 criteria (appendix a).
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
5. failed available therapy known to confer clinical benefit but no more than 4 prior lines of chemotherapy for metastatic disease.
Description

Therapy Available failed | Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
6. time to treatment failure from doxorubicin containing regimen ≥ 12 months if previously treated with doxorubicin.
Description

Treatment failure | Therapy Containing Doxorubicin

Data type

boolean

Alias
UMLS CUI [1]
C0162643
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0013089
7. age ≥ 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
8. ecog performance status of 0 - 2. -
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
Description

Communicable Disease Serious | Requirement Antibiotics for systemic use

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3540704
2. prior epirubicin exposure of > 600 mg/m2.
Description

Exposure to Epirubicin Dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0014582
UMLS CUI [1,3]
C0178602
3. pregnancy or lactation.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. expected non-compliance.
Description

Compliance behavior Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0750558
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association class iii or iv), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0742758
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0003811
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0439801
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
6. subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ grade 1 aes, or deemed irreversible from the effects of prior cancer therapy. aes > grade 1 that are not considered a safety risk by the sponsor and investigator may be allowed upon agreement with both.
Description

Cancer treatment | Recovery Lacking | Exception Alopecia | Absence Recovery CTCAE Grades | Irreversible toxic effect Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C2004454
UMLS CUI [4,3]
C1516728
UMLS CUI [5,1]
C0678774
UMLS CUI [5,2]
C0920425
7. subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect subject outcome in the setting of breast cancer diagnosis.
Description

Cancer Other Primary | Second Cancer | Exception Skin carcinoma Resected Curative | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Solid tumor Disease Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0751623
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1521996
UMLS CUI [3,4]
C1276305
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0280100
UMLS CUI [5,3]
C0012634
UMLS CUI [5,4]
C0332296
8. subjects who had been treated with adi-peg 20 previously.
Description

ADI PEG20

Data type

boolean

Alias
UMLS CUI [1]
C1328192
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Similar models

Eligibility HER2 Negative Metastatic Breast Cancer NCT01948843

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast HER2 Negative | Dose Escalation | Maximum Tolerated Dose | Advanced solid tumor
Item
1. biopsy proven her2 negative metastatic breast cancer (dose escalation portion and mtd expansion portion) or advanced solid tumor (dose escalation portion).
boolean
C0346993 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C3816728 (UMLS CUI [2])
C0752079 (UMLS CUI [3])
C4329281 (UMLS CUI [4])
ASS deficiency | Tissue specimen Immunohistochemistry
Item
2. ass deficiency (defined as <50% ass expression) demonstrated on tissue specimen by immunohistochemistry (ihc). cytology and fine need aspirate specimens are not acceptable for ass testing.
boolean
C0175683 (UMLS CUI [1])
C1292533 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
Disease unresectable | Study Subject Refused Surgery
Item
3. unresectable disease or subject refused surgery.
boolean
C0012634 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0749192 (UMLS CUI [2,2])
Measurable Disease
Item
4. measurable disease as assessed by recist 1.1 criteria (appendix a).
boolean
C1513041 (UMLS CUI [1])
Therapy Available failed | Chemotherapy Quantity Neoplasm Metastasis
Item
5. failed available therapy known to confer clinical benefit but no more than 4 prior lines of chemotherapy for metastatic disease.
boolean
C0087111 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Treatment failure | Therapy Containing Doxorubicin
Item
6. time to treatment failure from doxorubicin containing regimen ≥ 12 months if previously treated with doxorubicin.
boolean
C0162643 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0013089 (UMLS CUI [2,3])
Age
Item
7. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
8. ecog performance status of 0 - 2. -
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Serious | Requirement Antibiotics for systemic use
Item
1. serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C3540704 (UMLS CUI [2,2])
Exposure to Epirubicin Dosage
Item
2. prior epirubicin exposure of > 600 mg/m2.
boolean
C0332157 (UMLS CUI [1,1])
C0014582 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
3. pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Compliance behavior Unlikely
Item
4. expected non-compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (new york heart association class iii or iv), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Cancer treatment | Recovery Lacking | Exception Alopecia | Absence Recovery CTCAE Grades | Irreversible toxic effect Cancer treatment
Item
6. subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ grade 1 aes, or deemed irreversible from the effects of prior cancer therapy. aes > grade 1 that are not considered a safety risk by the sponsor and investigator may be allowed upon agreement with both.
boolean
C0920425 (UMLS CUI [1])
C2004454 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C2004454 (UMLS CUI [4,2])
C1516728 (UMLS CUI [4,3])
C0678774 (UMLS CUI [5,1])
C0920425 (UMLS CUI [5,2])
Cancer Other Primary | Second Cancer | Exception Skin carcinoma Resected Curative | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Solid tumor Disease Free of
Item
7. subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect subject outcome in the setting of breast cancer diagnosis.
boolean
C1707251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0751623 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1521996 (UMLS CUI [3,3])
C1276305 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0280100 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
C0332296 (UMLS CUI [5,4])
ADI PEG20
Item
8. subjects who had been treated with adi-peg 20 previously.
boolean
C1328192 (UMLS CUI [1])
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