ID

38621

Description

A Study Of Crizotinib Plus VEGF Inhibitor Combinations In Patients With Advanced Solid Tumors.; ODM derived from: https://clinicaltrials.gov/show/NCT01441388

Link

https://clinicaltrials.gov/show/NCT01441388

Keywords

  1. 10/28/19 10/28/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 28, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Carcinoma, Renal Cell NCT01441388

Eligibility Carcinoma, Renal Cell NCT01441388

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
dose escalation population: histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available. lesions may be measurable or non measurable.
Description

Advanced Malignant Solid Neoplasm Resistant to Standard therapy | Metastatic Malignant Solid Neoplasm Resistant to Standard therapy | Standard therapy Unavailable | Measurable lesion | Non-Measurable Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C4329281
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C2936643
UMLS CUI [2,1]
C4287832
UMLS CUI [2,2]
C0332325
UMLS CUI [2,3]
C2936643
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0686905
UMLS CUI [4]
C1513041
UMLS CUI [5]
C1334988
expansion population 1: patients with histologically confirmed metastatic renal cell cancer with no prior systemic therapy directed at the malignant tumor.
Description

Metastatic Renal Cell Cancer | Systemic therapy Absent Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0278678
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0006826
expansion population 2: patients with histologically confirmed metastatic renal cell cancer whose prior systemic therapy directed at the malignant tumor was single agent vegf inhibitor and who now have acquired resistance to this treatment. resistance is defined as progression following an initial response (complete or partial), or stable disease for at least 6 months on single agent vegf inhibitor.
Description

Metastatic Renal Cell Cancer | Systemic therapy Malignant Neoplasm | VEGF Inhibitor | Resistant to VEGF Inhibitor | Disease Progression Following Response | In complete remission | Partial response | Stable Disease Duration

Data type

boolean

Alias
UMLS CUI [1]
C0278678
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0006826
UMLS CUI [3]
C4521299
UMLS CUI [4,1]
C0332325
UMLS CUI [4,2]
C4521299
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0332282
UMLS CUI [5,3]
C1704632
UMLS CUI [6]
C0677874
UMLS CUI [7]
C1521726
UMLS CUI [8,1]
C0677946
UMLS CUI [8,2]
C0449238
expansion population 3: patients with histologically confirmed glioblastoma whose disease has failed on previous therapy, and which must have included treatment with external beam radiation and temozolomide chemotherapy, and who now have radiographically recurrent or progressive disease.
Description

Glioblastoma | Prior Therapy failed | Teleradiotherapy | Temozolomide Chemotherapy | Recurrent disease Radiography | Progressive Disease Radiography

Data type

boolean

Alias
UMLS CUI [1]
C0017636
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0419095
UMLS CUI [4,1]
C0076080
UMLS CUI [4,2]
C0392920
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C0034571
UMLS CUI [6,1]
C1335499
UMLS CUI [6,2]
C0034571
expansion population 4: patients with histologically confirmed advanced-stage (unresectable or metastatic) hepatocellular carcinoma who have not received previous systemic therapy directed at the malignant tumor will be eligible to receive crizotinib plus sorafenib, should this combination be tested. eligibility criteria also include normal hepatic function or child-pugh hepatic function class a.
Description

Liver carcinoma Advanced unresectable | Metastatic hepatocellular carcinoma Advanced | Systemic therapy Absent Malignant Neoplasm | Crizotinib plus Sorafenib | Liver function | Liver function Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1519810
UMLS CUI [2,1]
C0744869
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0006826
UMLS CUI [4,1]
C2974289
UMLS CUI [4,2]
C0332287
UMLS CUI [4,3]
C1516119
UMLS CUI [5]
C0232741
UMLS CUI [6,1]
C0232741
UMLS CUI [6,2]
C2347612
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with hemorrhagic brain metastases or with known symptomatic brain metastases requiring steroids.
Description

Metastatic malignant neoplasm to brain Hemorrhagic | Metastatic malignant neoplasm to brain Symptomatic | Requirement Steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0333275
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0038317
major surgery within 4 weeks of starting study treatment.
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
radiation therapy within 2 weeks of starting study treatment.
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
hypertension that cannot be controlled with medications (>150/90 mmhg despite optimal medical therapy).
Description

Uncontrolled hypertension | Blood pressure determination | Therapy Optimal

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2698651
for glioblastoma patients: prior treatment of glioblastoma with gliadel wafers, stereotactic radiation, or brachytherapy unless there is pathological or definitive radiological evidence (pet scan or perfusion mri) of recurrent tumor or unless there is new enhancement outside of the radiation field. history of grade 2 or greater acute intracranial hemorrhage. radiation therapy (rt) for glioblastoma within 3 months unless there is either: a) histopathologic confirmation of recurrent tumor, or b) new enhancement on mri outside of the rt treatment field.concomitant treatment with therapeutic doses of anticoagulants (low dose warfarin (coumadin) up to 2 mg po daily for deep vein thrombosis prophylaxis is allowed).
Description

Prior Therapy Glioblastoma | Gliadel wafer | Radiation Stereotactic | Brachytherapy | Exception Recurrent tumor PET scan | Exception Recurrent tumor Perfusion MRI | Intracranial Hemorrhage CTCAE Grades | Therapeutic radiology procedure Glioblastoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0017636
UMLS CUI [2]
C1171407
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0729296
UMLS CUI [4]
C0006098
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0521158
UMLS CUI [5,3]
C0032743
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0521158
UMLS CUI [6,3]
C0879554
UMLS CUI [7,1]
C0151699
UMLS CUI [7,2]
C1516728
UMLS CUI [8,1]
C1522449
UMLS CUI [8,2]
C0017636

Similar models

Eligibility Carcinoma, Renal Cell NCT01441388

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Advanced Malignant Solid Neoplasm Resistant to Standard therapy | Metastatic Malignant Solid Neoplasm Resistant to Standard therapy | Standard therapy Unavailable | Measurable lesion | Non-Measurable Lesion
Item
dose escalation population: histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available. lesions may be measurable or non measurable.
boolean
C4329281 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
C4287832 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4])
C1334988 (UMLS CUI [5])
Metastatic Renal Cell Cancer | Systemic therapy Absent Malignant Neoplasm
Item
expansion population 1: patients with histologically confirmed metastatic renal cell cancer with no prior systemic therapy directed at the malignant tumor.
boolean
C0278678 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Metastatic Renal Cell Cancer | Systemic therapy Malignant Neoplasm | VEGF Inhibitor | Resistant to VEGF Inhibitor | Disease Progression Following Response | In complete remission | Partial response | Stable Disease Duration
Item
expansion population 2: patients with histologically confirmed metastatic renal cell cancer whose prior systemic therapy directed at the malignant tumor was single agent vegf inhibitor and who now have acquired resistance to this treatment. resistance is defined as progression following an initial response (complete or partial), or stable disease for at least 6 months on single agent vegf inhibitor.
boolean
C0278678 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C4521299 (UMLS CUI [3])
C0332325 (UMLS CUI [4,1])
C4521299 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5,1])
C0332282 (UMLS CUI [5,2])
C1704632 (UMLS CUI [5,3])
C0677874 (UMLS CUI [6])
C1521726 (UMLS CUI [7])
C0677946 (UMLS CUI [8,1])
C0449238 (UMLS CUI [8,2])
Glioblastoma | Prior Therapy failed | Teleradiotherapy | Temozolomide Chemotherapy | Recurrent disease Radiography | Progressive Disease Radiography
Item
expansion population 3: patients with histologically confirmed glioblastoma whose disease has failed on previous therapy, and which must have included treatment with external beam radiation and temozolomide chemotherapy, and who now have radiographically recurrent or progressive disease.
boolean
C0017636 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0419095 (UMLS CUI [3])
C0076080 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5,1])
C0034571 (UMLS CUI [5,2])
C1335499 (UMLS CUI [6,1])
C0034571 (UMLS CUI [6,2])
Liver carcinoma Advanced unresectable | Metastatic hepatocellular carcinoma Advanced | Systemic therapy Absent Malignant Neoplasm | Crizotinib plus Sorafenib | Liver function | Liver function Child-Pugh Classification
Item
expansion population 4: patients with histologically confirmed advanced-stage (unresectable or metastatic) hepatocellular carcinoma who have not received previous systemic therapy directed at the malignant tumor will be eligible to receive crizotinib plus sorafenib, should this combination be tested. eligibility criteria also include normal hepatic function or child-pugh hepatic function class a.
boolean
C2239176 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1519810 (UMLS CUI [1,3])
C0744869 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C2974289 (UMLS CUI [4,1])
C0332287 (UMLS CUI [4,2])
C1516119 (UMLS CUI [4,3])
C0232741 (UMLS CUI [5])
C0232741 (UMLS CUI [6,1])
C2347612 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Hemorrhagic | Metastatic malignant neoplasm to brain Symptomatic | Requirement Steroids
Item
patients with hemorrhagic brain metastases or with known symptomatic brain metastases requiring steroids.
boolean
C0220650 (UMLS CUI [1,1])
C0333275 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
Major surgery
Item
major surgery within 4 weeks of starting study treatment.
boolean
C0679637 (UMLS CUI [1])
Therapeutic radiology procedure
Item
radiation therapy within 2 weeks of starting study treatment.
boolean
C1522449 (UMLS CUI [1])
Uncontrolled hypertension | Blood pressure determination | Therapy Optimal
Item
hypertension that cannot be controlled with medications (>150/90 mmhg despite optimal medical therapy).
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
Prior Therapy Glioblastoma | Gliadel wafer | Radiation Stereotactic | Brachytherapy | Exception Recurrent tumor PET scan | Exception Recurrent tumor Perfusion MRI | Intracranial Hemorrhage CTCAE Grades | Therapeutic radiology procedure Glioblastoma
Item
for glioblastoma patients: prior treatment of glioblastoma with gliadel wafers, stereotactic radiation, or brachytherapy unless there is pathological or definitive radiological evidence (pet scan or perfusion mri) of recurrent tumor or unless there is new enhancement outside of the radiation field. history of grade 2 or greater acute intracranial hemorrhage. radiation therapy (rt) for glioblastoma within 3 months unless there is either: a) histopathologic confirmation of recurrent tumor, or b) new enhancement on mri outside of the rt treatment field.concomitant treatment with therapeutic doses of anticoagulants (low dose warfarin (coumadin) up to 2 mg po daily for deep vein thrombosis prophylaxis is allowed).
boolean
C1514463 (UMLS CUI [1,1])
C0017636 (UMLS CUI [1,2])
C1171407 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0729296 (UMLS CUI [3,2])
C0006098 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0521158 (UMLS CUI [5,2])
C0032743 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0521158 (UMLS CUI [6,2])
C0879554 (UMLS CUI [6,3])
C0151699 (UMLS CUI [7,1])
C1516728 (UMLS CUI [7,2])
C1522449 (UMLS CUI [8,1])
C0017636 (UMLS CUI [8,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial