ID

37884

Description

A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01156753

Link

https://clinicaltrials.gov/show/NCT01156753

Keywords

Versions (1)
  1. 8/28/19 8/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01156753

English

Eligibility Breast Cancer NCT01156753

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
among other criteria, patients must meet all of the following conditions to be eligible for the study:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. locally advanced or metastatic breast cancer.
Description

Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
3. previous treatment with at least two but no more than seven prior chemotherapy treatments for progressive, recurrent or metastatic breast cancer.
Description

Prior Chemotherapy Quantity Breast Carcinoma Progressive | Prior Chemotherapy Quantity Breast cancer recurrent | Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0678222
UMLS CUI [1,4]
C0205329
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0278493
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0346993
4. unless not a candidate for these agents, prior therapies must have included a taxane, an anthracycline, and capecitabine, as well as trastuzumab and lapatinib for patients whose tumors are positive for the human epidermal growth factor receptor 2 (her2). (patients who received incomplete courses of therapy with these agents due to intolerance will be eligible.)
Description

Exception Patient Inappropriate Pharmaceutical Preparations | Prior Therapy Including Pharmaceutical Preparations | taxane | Anthracycline | capecitabine | trastuzumab | lapatinib | Tumor HER2 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1548788
UMLS CUI [1,4]
C0013227
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0332257
UMLS CUI [2,3]
C0013227
UMLS CUI [3]
C0215136
UMLS CUI [4]
C0282564
UMLS CUI [5]
C0671970
UMLS CUI [6]
C0728747
UMLS CUI [7]
C1506770
UMLS CUI [8,1]
C0027651
UMLS CUI [8,2]
C2348909
5. breast cancer tumor confirmed to express gpnmb. this will be determined by submitting a tissue sample (obtained during a diagnostic biopsy or surgery) to a central laboratory for analysis.
Description

Breast Carcinoma GPNMB Expression | Determined by Tissue specimen Analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1415205
UMLS CUI [1,3]
C0017262
UMLS CUI [2,1]
C0521095
UMLS CUI [2,2]
C1292533
UMLS CUI [2,3]
C0002778
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
among other criteria, patients who meet any of the following conditions are not eligible for the study:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (grade 2) or worse in severity.
Description

Neuropathy CTCAE Grades | Toxicity CTCAE Grades | Relationship Chemotherapy | Relationship Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1516728
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0392920
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C1522449
2. known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
Description

Metastatic malignant neoplasm to brain | Exception Prior Therapy | Exception Disease Asymptomatic | Exception Progressive Disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0231221
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1335499
UMLS CUI [4,3]
C0332197
3. significant cardiovascular disease or any other underlying medical condition that, in the investigator's opinion, will make the administration of study treatment (cdx-011 or chemotherapy) hazardous or would obscure the interpretation of side effects.
Description

Cardiovascular Disease | Medical condition Investigational Therapy At risk | CDX-011 | Chemotherapy | Medical condition Interferes with Interpretation Side effects

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0949266
UMLS CUI [2,3]
C1444641
UMLS CUI [3]
C2935737
UMLS CUI [4]
C0392920
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0879626
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Similar models

Eligibility Breast Cancer NCT01156753

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
among other criteria, patients must meet all of the following conditions to be eligible for the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
1. 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
2. locally advanced or metastatic breast cancer.
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Prior Chemotherapy Quantity Breast Carcinoma Progressive | Prior Chemotherapy Quantity Breast cancer recurrent | Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
3. previous treatment with at least two but no more than seven prior chemotherapy treatments for progressive, recurrent or metastatic breast cancer.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0205329 (UMLS CUI [1,4])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0278493 (UMLS CUI [2,3])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0346993 (UMLS CUI [3,3])
Exception Patient Inappropriate Pharmaceutical Preparations | Prior Therapy Including Pharmaceutical Preparations | taxane | Anthracycline | capecitabine | trastuzumab | lapatinib | Tumor HER2 Positive
Item
4. unless not a candidate for these agents, prior therapies must have included a taxane, an anthracycline, and capecitabine, as well as trastuzumab and lapatinib for patients whose tumors are positive for the human epidermal growth factor receptor 2 (her2). (patients who received incomplete courses of therapy with these agents due to intolerance will be eligible.)
boolean
C1705847 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C1514463 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0215136 (UMLS CUI [3])
C0282564 (UMLS CUI [4])
C0671970 (UMLS CUI [5])
C0728747 (UMLS CUI [6])
C1506770 (UMLS CUI [7])
C0027651 (UMLS CUI [8,1])
C2348909 (UMLS CUI [8,2])
Breast Carcinoma GPNMB Expression | Determined by Tissue specimen Analysis
Item
5. breast cancer tumor confirmed to express gpnmb. this will be determined by submitting a tissue sample (obtained during a diagnostic biopsy or surgery) to a central laboratory for analysis.
boolean
C0678222 (UMLS CUI [1,1])
C1415205 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
C0521095 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C0002778 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
among other criteria, patients who meet any of the following conditions are not eligible for the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Neuropathy CTCAE Grades | Toxicity CTCAE Grades | Relationship Chemotherapy | Relationship Therapeutic radiology procedure
Item
1. ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (grade 2) or worse in severity.
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain | Exception Prior Therapy | Exception Disease Asymptomatic | Exception Progressive Disease Absent
Item
2. known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0231221 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1335499 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Cardiovascular Disease | Medical condition Investigational Therapy At risk | CDX-011 | Chemotherapy | Medical condition Interferes with Interpretation Side effects
Item
3. significant cardiovascular disease or any other underlying medical condition that, in the investigator's opinion, will make the administration of study treatment (cdx-011 or chemotherapy) hazardous or would obscure the interpretation of side effects.
boolean
C0007222 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C2935737 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0879626 (UMLS CUI [5,4])
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