ID

37978

Beskrivning

A Clinical Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin; ODM derived from: https://clinicaltrials.gov/show/NCT01333137

Länk

https://clinicaltrials.gov/show/NCT01333137

Nyckelord

Versioner (1)
  1. 2019-09-04 2019-09-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01333137

Engelsk

Eligibility Breast Cancer NCT01333137

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. females of age ≥18 years.
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histologically documented metastatic triple negative breast cancer (any triple negative breast cancer for phase i)
Beskrivning

Triple Negative Breast Neoplasm metastatic | Triple Negative Breast Neoplasm Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C3539878
UMLS CUI [2,2]
C1552551
3. two or fewer chemotherapy regimens for advanced disease (no limit of prior regimens for phase i)
Beskrivning

Chemotherapy Regimen Quantity Advanced disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679246
4. ecog performance score of 1 or less
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. presence of measurable disease by recist 1.1 criteria (not for the phase i portion)
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
6. ability to understand and the willingness to sign a written informed consent document (icd)
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
7. full recovery from all prior treatment toxicities to common terminology criteria for adverse events (ctcae v.4) grade ≤ 1
Beskrivning

Toxicity Due to Prior Therapy | Recovery Full CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0443225
UMLS CUI [2,3]
C1516728
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
Beskrivning

Prior Chemotherapy | Antineoplastic Biological Agent | Antineoplastic Agents Targeted

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C4329349
UMLS CUI [3,1]
C0003392
UMLS CUI [3,2]
C1521840
2. prior radiation therapy within 6 weeks of study drug administration
Beskrivning

Prior radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279134
3. subject with known active cns metastases and/or carcinomatous meningitis. however, subjects with cns metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to entry as defined as: (1) no evidence of new or enlarging cns metastasis or new neurological symptoms attributable to cns metastases (2) off steroids that are used to minimize surrounding brain edema.
Beskrivning

CNS metastases | Meningeal Carcinomatosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220654
4. prior therapy with gemcitabine or a platinum agent (not for the phase i part)
Beskrivning

gemcitabine | Platinum-based Drug

Datatyp

boolean

Alias
UMLS CUI [1]
C0045093
UMLS CUI [2]
C2266918
5. prior therapy with a cdk/cyclin inhibitor or any flavones derivative
Beskrivning

Cyclin-Dependent Kinase Inhibitor Agents | Flavones Derivative

Datatyp

boolean

Alias
UMLS CUI [1]
C1511576
UMLS CUI [2,1]
C0016219
UMLS CUI [2,2]
C1527240
6. qtc interval >450 msec (using fridericia's formula)
Beskrivning

Q-T interval corrected based on Fridericia formula

Datatyp

boolean

Alias
UMLS CUI [1]
C4037594
7. any acute illness including uncontrolled diabetes, symptomatic or otherwise uncontrolled cardiac disease (coronary artery disease, arrhythmias, congestive heart failure) or other illness that in the judgment of the investigator would introduce additional medical risks
Beskrivning

Acute illness | Diabetic - poor control | Heart Disease Symptomatic | Heart Disease Uncontrolled | Coronary Artery Disease | Cardiac Arrhythmia | Congestive heart failure | Illness Inducing Risk factors

Datatyp

boolean

Alias
UMLS CUI [1]
C4061114
UMLS CUI [2]
C0421258
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0231220
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C1956346
UMLS CUI [6]
C0003811
UMLS CUI [7]
C0018802
UMLS CUI [8,1]
C0221423
UMLS CUI [8,2]
C0205263
UMLS CUI [8,3]
C0035648
8. visceral crisis including extensive liver disease with>50% parenchymal involvement or lymphangitic pulmonary disease
Beskrivning

Visceral Crisis | Liver disease Extensive | Involvement with Parenchymal Tissue Percentage | Lymphangitis carcinomatosa Pulmonary

Datatyp

boolean

Alias
UMLS CUI [1]
C4527413
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205231
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C4277702
UMLS CUI [3,3]
C0439165
UMLS CUI [4,1]
C0238258
UMLS CUI [4,2]
C2709248
9. history of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, or in situ breast cancer
Beskrivning

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0686288
UMLS CUI [5,3]
C1522326
10. expected survival of less than 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
11. hemoglobin <9.0 gm/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
12. absolute neutrophil count <1500/mm3
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
13. platelet count <100,000/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
14. alanine aminotransferase (alt) and aspartate aminotransferase (ast) >3 ×
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
institutional upper limit of normal (uln)
Beskrivning

ID.22

Datatyp

boolean

15. total bilirubin, >1.5 × institutional uln
Beskrivning

Elevated total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
16. serum creatinine >1.5 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
17. subjects with known infection with human immunodeficiency virus (hiv), tuberculosis, hepatitis c or hepatitis b
Beskrivning

HIV Infection | Tuberculosis | Hepatitis C | Hepatitis B

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0041296
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019163
18. pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
19. women of childbearing potential not willing to use approved methods of contraception after signing the icd, during the entire study and for at least 4 weeks after completion of study or following withdrawal from the study
Beskrivning

Childbearing Potential Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
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Similar models

Eligibility Breast Cancer NCT01333137

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. females of age ≥18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Triple Negative Breast Neoplasm metastatic | Triple Negative Breast Neoplasm Any
Item
2. histologically documented metastatic triple negative breast cancer (any triple negative breast cancer for phase i)
boolean
C3539878 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C3539878 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Chemotherapy Regimen Quantity Advanced disease
Item
3. two or fewer chemotherapy regimens for advanced disease (no limit of prior regimens for phase i)
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
ECOG performance status
Item
4. ecog performance score of 1 or less
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
5. presence of measurable disease by recist 1.1 criteria (not for the phase i portion)
boolean
C1513041 (UMLS CUI [1])
Informed Consent
Item
6. ability to understand and the willingness to sign a written informed consent document (icd)
boolean
C0021430 (UMLS CUI [1])
Toxicity Due to Prior Therapy | Recovery Full CTCAE Grades
Item
7. full recovery from all prior treatment toxicities to common terminology criteria for adverse events (ctcae v.4) grade ≤ 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C2004454 (UMLS CUI [2,1])
C0443225 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy | Antineoplastic Biological Agent | Antineoplastic Agents Targeted
Item
1. prior chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
boolean
C1514457 (UMLS CUI [1])
C4329349 (UMLS CUI [2])
C0003392 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
Prior radiation therapy
Item
2. prior radiation therapy within 6 weeks of study drug administration
boolean
C0279134 (UMLS CUI [1])
CNS metastases | Meningeal Carcinomatosis
Item
3. subject with known active cns metastases and/or carcinomatous meningitis. however, subjects with cns metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to entry as defined as: (1) no evidence of new or enlarging cns metastasis or new neurological symptoms attributable to cns metastases (2) off steroids that are used to minimize surrounding brain edema.
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
gemcitabine | Platinum-based Drug
Item
4. prior therapy with gemcitabine or a platinum agent (not for the phase i part)
boolean
C0045093 (UMLS CUI [1])
C2266918 (UMLS CUI [2])
Cyclin-Dependent Kinase Inhibitor Agents | Flavones Derivative
Item
5. prior therapy with a cdk/cyclin inhibitor or any flavones derivative
boolean
C1511576 (UMLS CUI [1])
C0016219 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
Q-T interval corrected based on Fridericia formula
Item
6. qtc interval >450 msec (using fridericia's formula)
boolean
C4037594 (UMLS CUI [1])
Acute illness | Diabetic - poor control | Heart Disease Symptomatic | Heart Disease Uncontrolled | Coronary Artery Disease | Cardiac Arrhythmia | Congestive heart failure | Illness Inducing Risk factors
Item
7. any acute illness including uncontrolled diabetes, symptomatic or otherwise uncontrolled cardiac disease (coronary artery disease, arrhythmias, congestive heart failure) or other illness that in the judgment of the investigator would introduce additional medical risks
boolean
C4061114 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1956346 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C0221423 (UMLS CUI [8,1])
C0205263 (UMLS CUI [8,2])
C0035648 (UMLS CUI [8,3])
Visceral Crisis | Liver disease Extensive | Involvement with Parenchymal Tissue Percentage | Lymphangitis carcinomatosa Pulmonary
Item
8. visceral crisis including extensive liver disease with>50% parenchymal involvement or lymphangitic pulmonary disease
boolean
C4527413 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C4277702 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0238258 (UMLS CUI [4,1])
C2709248 (UMLS CUI [4,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Carcinoma in situ of female breast Treated
Item
9. history of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, or in situ breast cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0686288 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Life Expectancy
Item
10. expected survival of less than 3 months
boolean
C0023671 (UMLS CUI [1])
Hemoglobin measurement
Item
11. hemoglobin <9.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
12. absolute neutrophil count <1500/mm3
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
13. platelet count <100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
14. alanine aminotransferase (alt) and aspartate aminotransferase (ast) >3 ×
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
ID.22
Item
institutional upper limit of normal (uln)
boolean
Elevated total bilirubin
Item
15. total bilirubin, >1.5 × institutional uln
boolean
C0741494 (UMLS CUI [1])
Creatinine measurement, serum
Item
16. serum creatinine >1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
HIV Infection | Tuberculosis | Hepatitis C | Hepatitis B
Item
17. subjects with known infection with human immunodeficiency virus (hiv), tuberculosis, hepatitis c or hepatitis b
boolean
C0019693 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
18. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
19. women of childbearing potential not willing to use approved methods of contraception after signing the icd, during the entire study and for at least 4 weeks after completion of study or following withdrawal from the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
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