ID

31221

Description

A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00975182

Link

https://clinicaltrials.gov/show/NCT00975182

Keywords

Versions (1)
  1. 7/30/18 7/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 30, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers NCT00975182

English

Eligibility Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers NCT00975182

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
Description

Solid Neoplasm Advanced Locally | Solid Neoplasm metastatic | Standard therapy Lacking | Standard therapy ineffective | Intolerance Standard therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0332268
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C3242229
UMLS CUI [5,1]
C0231199
UMLS CUI [5,2]
C2936643
documented locally advanced or metastatic nsclc in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
Description

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Prior Chemotherapy Quantity failed Incurable disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0231175
UMLS CUI [3,4]
C0175969
adequate organ function as assessed by laboratory tests
Description

Organ function Laboratory tests

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0022885
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
Description

Evaluable Disease | Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2]
C1513041
agreement to use an effective form of contraception for the duration of the study
Description

Contraceptive methods Agreement

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0680240
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
Description

Cancer treatment | Chemotherapy | Biological treatment | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0279025
prior treatment with pi3k pathway-inhibiting agents (cohort-expansion stage only)
Description

PI3k Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0044602
UMLS CUI [1,2]
C1999216
history of grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
Description

Fasting hyperglycaemia Grade | Diabetes Mellitus Requirement Pharmaceutical Preparations Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C2609269
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013227
UMLS CUI [2,4]
C0205272
current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
Description

Systemic disease Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0025517
history of clinically significant cardiac or pulmonary dysfunction
Description

Cardiac dysfunction | Pulmonary Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C3277906
UMLS CUI [2]
C1709770
history of malabsorption syndrome or other condition that would interfere with enteral absorption
Description

Malabsorption Syndrome | Condition Interferes with Intestinal Absorption

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021826
clinically significant history of liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
Description

Condition Requirement Anticoagulants Dose Full | Warfarin | Heparin | Fibrinolytic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003280
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C0443225
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0019134
UMLS CUI [4]
C0016018
active autoimmune disease and/or need for corticosteroid therapy
Description

Autoimmune Disease | Patient need for Steroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0149783
known brain metastases that are untreated, symptomatic, or require therapy
Description

Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0332121
pregnancy, lactation, or breastfeeding
Description

Pregnancy | Lactation | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
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Similar models

Eligibility Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers NCT00975182

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Solid Neoplasm Advanced Locally | Solid Neoplasm metastatic | Standard therapy Lacking | Standard therapy ineffective | Intolerance Standard therapy
Item
documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
boolean
C0280100 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0280100 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C3242229 (UMLS CUI [4,2])
C0231199 (UMLS CUI [5,1])
C2936643 (UMLS CUI [5,2])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | Prior Chemotherapy Quantity failed Incurable disease
Item
documented locally advanced or metastatic nsclc in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C0175969 (UMLS CUI [3,4])
Organ function Laboratory tests
Item
adequate organ function as assessed by laboratory tests
boolean
C0678852 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Evaluable Disease | Measurable Disease
Item
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Contraceptive methods Agreement
Item
agreement to use an effective form of contraception for the duration of the study
boolean
C0700589 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment | Chemotherapy | Biological treatment | Hormone Therapy
Item
any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
PI3k Inhibitor
Item
prior treatment with pi3k pathway-inhibiting agents (cohort-expansion stage only)
boolean
C0044602 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
Fasting hyperglycaemia Grade | Diabetes Mellitus Requirement Pharmaceutical Preparations Regular
Item
history of grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
boolean
C2609269 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0205272 (UMLS CUI [2,4])
Systemic disease Uncontrolled | Cardiovascular Disease | Lung disease | Metabolic Disease
Item
current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
Cardiac dysfunction | Pulmonary Dysfunction
Item
history of clinically significant cardiac or pulmonary dysfunction
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
Malabsorption Syndrome | Condition Interferes with Intestinal Absorption
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021826 (UMLS CUI [2,3])
Liver disease
Item
clinically significant history of liver disease
boolean
C0023895 (UMLS CUI [1])
Condition Requirement Anticoagulants Dose Full | Warfarin | Heparin | Fibrinolytic Agents
Item
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C0443225 (UMLS CUI [1,5])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0016018 (UMLS CUI [4])
Autoimmune Disease | Patient need for Steroid therapy
Item
active autoimmune disease and/or need for corticosteroid therapy
boolean
C0004364 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0149783 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Treatment required for
Item
known brain metastases that are untreated, symptomatic, or require therapy
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
Pregnancy | Lactation | Breast Feeding
Item
pregnancy, lactation, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
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