ID

18102

Description

MEK Inhibitor PD-325901 To Treat Advanced Breast Cancer, Colon Cancer, And Melanoma.; ODM derived from: https://clinicaltrials.gov/show/NCT00147550

Link

https://clinicaltrials.gov/show/NCT00147550

Keywords

Versions (1)
  1. 10/19/16 10/19/16 -
Uploaded on

October 19, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Melanoma NCT00147550

English

Eligibility Melanoma NCT00147550

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00147550
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >= 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
tumor accessible for biopsy and willingness to undergo baseline and 1 post treatment biopsy
Description

Malignant Neoplasm Amenable Biopsy | Biopsy Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0005558
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0600109
biopsiable, histologically or cytologically confirmed metastatic or inoperable breast cancer, colon cancer, or melanoma. prior treatment requirement : i) no more than 2 prior cytotoxic chemotherapy regimens for metastatic disease for patients with breast or colon cancers; ii) no prio cytotoxic therapy for patients with melanoma, or iii) measurable lesion (s) that have not been irradiated.
Description

Carcinoma breast stage IV | Malignant neoplasm of breast Inoperable | Malignant neoplasm of colon stage IV | Malignant tumor of colon Inoperable | Metastatic melanoma | melanoma Inoperable | Prior Therapy | Cytotoxic Chemotherapy Quantity Metastatic Neoplasm | Cytotoxic Chemotherapy melanoma | Therapeutic radiology procedure Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2,1]
C0006142
UMLS CUI [2,2]
C0205187
UMLS CUI [3]
C0278484
UMLS CUI [4,1]
C0007102
UMLS CUI [4,2]
C0205187
UMLS CUI [5]
C0278883
UMLS CUI [6,1]
C0025202
UMLS CUI [6,2]
C0205187
UMLS CUI [7]
C1514463
UMLS CUI [8,1]
C0677881
UMLS CUI [8,2]
C1265611
UMLS CUI [8,3]
C2939420
UMLS CUI [9,1]
C0677881
UMLS CUI [9,2]
C0025202
UMLS CUI [10,1]
C1522449
UMLS CUI [10,2]
C1513041
adequate renal, liver, and bone marrow function, determined within 2 weeks prior to the first treatment, defined as the following: serum creatinine <1.5 x uln, total bilirubin <2 x uln, aspartate aminotransferase (ast) or alanine aminotransferase (alt) <3 x uln (<5 x uln for patients with liver involvement); absolute neutrophil count (anc) >1500/ul; and platelet >100,000/ul
Description

Renal function | Liver function | Bone Marrow function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Involvement | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
UMLS CUI [4]
C0201976
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201899
UMLS CUI [7]
C0201836
UMLS CUI [8,1]
C0023884
UMLS CUI [8,2]
C1314939
UMLS CUI [9]
C0948762
UMLS CUI [10]
C0032181
hemoglobin >9.0 g/dl. treatment with transfusions or erythropoietin to elevate the hemoglobin level for eligibility purposes is not permitted. patients must have discontinued erythropoietin at least 2 weeks prior to the first dose of study medication
Description

Hemoglobin | Blood Transfusion | Erythropoietin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0005841
UMLS CUI [3]
C0014822
serum calcium <1 x uln and phosphorus <1 x uln
Description

Serum calcium measurement | Phosphorus measurement

Data type

boolean

Alias
UMLS CUI [1]
C0728876
UMLS CUI [2]
C0202178
patients having reproductive potential must use adequate method of birth control. patients may not be pregnant or breastfeeding.
Description

Fertility Contraceptive methods | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
ecog status of 0,1, or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must be able to swallow intact study medication and have no gastrointestinal disorders that may affect absorption of the drug
Description

Able to swallow Investigational New Drugs | Gastrointestinal Diseases Affecting drug absorption

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0678745
must be able to follow instructions or protocol specified procedures, or have a daily care giver who will be responsible for administering study medication.
Description

Protocol Compliance | Caregiver Administration of medication

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0085537
UMLS CUI [2,2]
C3469597
must be able to give written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no parathyroid disorder or history of malignancy associated hypercalcemia
Description

Parathyroid Diseases | Hypercalcemia Associated with Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0030517
UMLS CUI [2,1]
C0020437
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0006826
no ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; no immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
Description

Therapeutic radiology procedure | Cytotoxic Chemotherapy | Immunotherapy | Biological treatment | Hormone Therapy | Molecular Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0677881
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1531518
UMLS CUI [5]
C0279025
UMLS CUI [6]
C2699893
no concurrent serious infection or life-threatening illness (unrelated to tumor)
Description

Communicable Disease Serious | Life threatening illness Relationship Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3846017
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0006826
no history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years
Description

Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix | Disease In complete remission

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0677874
no untreated brain metastases.
Description

Metastatic malignant neoplasm to brain untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
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Similar models

Eligibility Melanoma NCT00147550

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT00147550
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >= 18 years old
boolean
C0001779 (UMLS CUI [1])
Malignant Neoplasm Amenable Biopsy | Biopsy Willing
Item
tumor accessible for biopsy and willingness to undergo baseline and 1 post treatment biopsy
boolean
C0006826 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Carcinoma breast stage IV | Malignant neoplasm of breast Inoperable | Malignant neoplasm of colon stage IV | Malignant tumor of colon Inoperable | Metastatic melanoma | melanoma Inoperable | Prior Therapy | Cytotoxic Chemotherapy Quantity Metastatic Neoplasm | Cytotoxic Chemotherapy melanoma | Therapeutic radiology procedure Measurable Disease
Item
biopsiable, histologically or cytologically confirmed metastatic or inoperable breast cancer, colon cancer, or melanoma. prior treatment requirement : i) no more than 2 prior cytotoxic chemotherapy regimens for metastatic disease for patients with breast or colon cancers; ii) no prio cytotoxic therapy for patients with melanoma, or iii) measurable lesion (s) that have not been irradiated.
boolean
C0278488 (UMLS CUI [1])
C0006142 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C0278484 (UMLS CUI [3])
C0007102 (UMLS CUI [4,1])
C0205187 (UMLS CUI [4,2])
C0278883 (UMLS CUI [5])
C0025202 (UMLS CUI [6,1])
C0205187 (UMLS CUI [6,2])
C1514463 (UMLS CUI [7])
C0677881 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C2939420 (UMLS CUI [8,3])
C0677881 (UMLS CUI [9,1])
C0025202 (UMLS CUI [9,2])
C1522449 (UMLS CUI [10,1])
C1513041 (UMLS CUI [10,2])
Renal function | Liver function | Bone Marrow function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Involvement | Absolute neutrophil count | Platelet Count measurement
Item
adequate renal, liver, and bone marrow function, determined within 2 weeks prior to the first treatment, defined as the following: serum creatinine <1.5 x uln, total bilirubin <2 x uln, aspartate aminotransferase (ast) or alanine aminotransferase (alt) <3 x uln (<5 x uln for patients with liver involvement); absolute neutrophil count (anc) >1500/ul; and platelet >100,000/ul
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0201976 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0023884 (UMLS CUI [8,1])
C1314939 (UMLS CUI [8,2])
C0948762 (UMLS CUI [9])
C0032181 (UMLS CUI [10])
Hemoglobin | Blood Transfusion | Erythropoietin
Item
hemoglobin >9.0 g/dl. treatment with transfusions or erythropoietin to elevate the hemoglobin level for eligibility purposes is not permitted. patients must have discontinued erythropoietin at least 2 weeks prior to the first dose of study medication
boolean
C0019046 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
Serum calcium measurement | Phosphorus measurement
Item
serum calcium <1 x uln and phosphorus <1 x uln
boolean
C0728876 (UMLS CUI [1])
C0202178 (UMLS CUI [2])
Fertility Contraceptive methods | Pregnancy | Breast Feeding
Item
patients having reproductive potential must use adequate method of birth control. patients may not be pregnant or breastfeeding.
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
ECOG performance status
Item
ecog status of 0,1, or 2.
boolean
C1520224 (UMLS CUI [1])
Able to swallow Investigational New Drugs | Gastrointestinal Diseases Affecting drug absorption
Item
must be able to swallow intact study medication and have no gastrointestinal disorders that may affect absorption of the drug
boolean
C2712086 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
Protocol Compliance | Caregiver Administration of medication
Item
must be able to follow instructions or protocol specified procedures, or have a daily care giver who will be responsible for administering study medication.
boolean
C0525058 (UMLS CUI [1])
C0085537 (UMLS CUI [2,1])
C3469597 (UMLS CUI [2,2])
Informed Consent
Item
must be able to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Parathyroid Diseases | Hypercalcemia Associated with Malignant Neoplasms
Item
no parathyroid disorder or history of malignancy associated hypercalcemia
boolean
C0030517 (UMLS CUI [1])
C0020437 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Therapeutic radiology procedure | Cytotoxic Chemotherapy | Immunotherapy | Biological treatment | Hormone Therapy | Molecular Targeted Therapy
Item
no ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; no immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
boolean
C1522449 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C2699893 (UMLS CUI [6])
Communicable Disease Serious | Life threatening illness Relationship Malignant Neoplasm
Item
no concurrent serious infection or life-threatening illness (unrelated to tumor)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3846017 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix | Disease In complete remission
Item
no history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0677874 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain untreated
Item
no untreated brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
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