ID

44658

Description

Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin; ODM derived from: https://clinicaltrials.gov/show/NCT02029690

Lien

https://clinicaltrials.gov/show/NCT02029690

Mots-clés

Versions (2)
  1. 14/06/2019 14/06/2019 -
  2. 27/09/2021 27/09/2021 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

27 septembre 2021

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Pleural Mesothelioma Malignant Advanced NCT02029690

Anglais

Eligibility Pleural Mesothelioma Malignant Advanced NCT02029690

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven advanced mpm, advanced peritoneal mesothelioma (for dose escalation cohort only) or non-squamous nsclc (stage iiib/iv) who have not been treated with prior chemotherapy or immunotherapy, except that nsclc subjects with egfr mutant or alk positive must have had an egfr tyrosine kinase inhibitor (tki) or alk inhibitor and progressed or been shown to be intolerant of therapy prior to enrolling in this trial, if such alk inhibitor and egfr targeted therapy are approved and available in the country in which patients are being enrolled or histologically proven metastatic uveal melanoma who have not been treated with prior chemotherapy (mtd cohort only), or histologically proven hcc who have failed (pd and/or side effects-been intolerant of) treatment with sorafenib. failure is defined as having progressed radiographically on, or been intolerant to prior systemic therapy. intolerance is defined as discontinuation due to an ae(s) on prior systemic therapy that was unacceptable to the treating physician and / or patient, with or without dose interruption and modification. failure requires at least 14 days of treatment with sorafenib, except for a subject that has had a severe allergic reaction to sorafenib at any time, even less than 14 days of treatment with sorafenib and thus it would be imprudent to re-challenge them with that agent. cirrhotic status of child-pugh grade a-b7 must be present. child-pugh status should be determined based on clinical findings and laboratory data during the screening period (appendix e). subjects on anti-coagulants are to receive 1 point for their inr status, as they are presumed to have a <1.7 baseline pt/inr.", or histologically proven high-grade glioma who have failed (pd and/or side effects) treatment with radiotherapy ± temozolomide.
Description

Pleural mesothelioma malignant advanced | Peritoneal Mesothelioma Advanced | Non-squamous non-small cell lung cancer TNM clinical staging | Prior Chemotherapy Absent | Prior Immunotherapy Absent | Uveal melanoma metastatic | Liver carcinoma | Sorafenib failed | Disease Progression Radiography | Status Cirrhotic Child-Pugh Classification | Anticoagulant therapy | INR Status | Glioma Severe | Temozolomide failed

Type de données

boolean

Alias
UMLS CUI [1]
C0854889
UMLS CUI [2,1]
C1377610
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C4324656
UMLS CUI [3,2]
C3258246
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1514461
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0220633
UMLS CUI [6,2]
C1522484
UMLS CUI [7]
C2239176
UMLS CUI [8,1]
C1516119
UMLS CUI [8,2]
C0231175
UMLS CUI [9,1]
C0242656
UMLS CUI [9,2]
C0034571
UMLS CUI [10,1]
C0449438
UMLS CUI [10,2]
C0439686
UMLS CUI [10,3]
C4050412
UMLS CUI [11]
C0150457
UMLS CUI [12,1]
C0525032
UMLS CUI [12,2]
C0449438
UMLS CUI [13,1]
C0017638
UMLS CUI [13,2]
C0205082
UMLS CUI [14,1]
C0076080
UMLS CUI [14,2]
C0231175
2. ass1 deficiency (defined as ≤50% ass expression) demonstrated on tissue specimen (cytospin samples are acceptable) by immunohistochemistry (ihc). for subjects previously treated with chemotherapy, this specimen may have been obtained before that chemotherapy. a new tissue specimen obtained after most recent chemotherapy is not required. thus ass1 deficiency is required for entrance into the study. if tissue is not available to determine ass1 deficiency, then tissue must be obtained by biopsy to determine ass1 status.
Description

ASS1 Deficiency Tissue specimen Immunohistochemistry

Type de données

boolean

Alias
UMLS CUI [1,1]
C4527366
UMLS CUI [1,2]
C1292533
UMLS CUI [1,3]
C0021044
3. measurable disease as assessed by modified recist for mpm and by recist 1.1 criteria for peritoneal mesothelioma, nsclc, uveal melanoma, hcc and glioma (appendices a and b).
Description

Measurable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
4. ecog performance status of 0 - 1 (appendix c).
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
5. predicted life expectancy of at least 12 weeks.
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment.
Description

Therapeutic radiology procedure | Exception Intent Palliative | Targeted Therapy | Immunotherapy | Exception Immunotherapy Uveal melanoma

Type de données

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1283828
UMLS CUI [2,3]
C1285530
UMLS CUI [3]
C2985566
UMLS CUI [4]
C0021083
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0021083
UMLS CUI [5,3]
C0220633
2. ongoing toxic manifestations of previous treatments.
Description

Manifestations Toxic Due to Prior Therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C1280464
UMLS CUI [1,2]
C1407029
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1514463
3. symptomatic brain or spinal cord metastases (patients must be stable for > 3 months post radiotherapy or surgery) for subjects with mesothelioma, nsclc, uveal melanoma excludes subjects with hcc or glioma).
Description

Metastatic malignant neoplasm to brain Symptomatic | Secondary malignant neoplasm of spinal cord Symptomatic | Patient's condition stable Post Therapeutic radiology procedure | Patient's condition stable Post Operative Surgical Procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0347016
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C1282982
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1522449
UMLS CUI [4,1]
C1282982
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0543467
4. major thoracic or abdominal surgery from which the patient has not yet recovered.
Description

Thoracic Surgical Procedure Major | Operation on abdominal region Major | Recovery Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0524832
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0198482
UMLS CUI [2,2]
C0205164
UMLS CUI [3,1]
C2004454
UMLS CUI [3,2]
C0332268
5. serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior to the first dose of study treatment.
Description

Communicable Disease Serious | Requirement Antibiotics Intravenous | Communicable Disease Requirement Intravenous therapy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003232
UMLS CUI [2,3]
C1522726
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0455142
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Similar models

Eligibility Pleural Mesothelioma Malignant Advanced NCT02029690

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Pleural mesothelioma malignant advanced | Peritoneal Mesothelioma Advanced | Non-squamous non-small cell lung cancer TNM clinical staging | Prior Chemotherapy Absent | Prior Immunotherapy Absent | Uveal melanoma metastatic | Liver carcinoma | Sorafenib failed | Disease Progression Radiography | Status Cirrhotic Child-Pugh Classification | Anticoagulant therapy | INR Status | Glioma Severe | Temozolomide failed
Item
1. histologically proven advanced mpm, advanced peritoneal mesothelioma (for dose escalation cohort only) or non-squamous nsclc (stage iiib/iv) who have not been treated with prior chemotherapy or immunotherapy, except that nsclc subjects with egfr mutant or alk positive must have had an egfr tyrosine kinase inhibitor (tki) or alk inhibitor and progressed or been shown to be intolerant of therapy prior to enrolling in this trial, if such alk inhibitor and egfr targeted therapy are approved and available in the country in which patients are being enrolled or histologically proven metastatic uveal melanoma who have not been treated with prior chemotherapy (mtd cohort only), or histologically proven hcc who have failed (pd and/or side effects-been intolerant of) treatment with sorafenib. failure is defined as having progressed radiographically on, or been intolerant to prior systemic therapy. intolerance is defined as discontinuation due to an ae(s) on prior systemic therapy that was unacceptable to the treating physician and / or patient, with or without dose interruption and modification. failure requires at least 14 days of treatment with sorafenib, except for a subject that has had a severe allergic reaction to sorafenib at any time, even less than 14 days of treatment with sorafenib and thus it would be imprudent to re-challenge them with that agent. cirrhotic status of child-pugh grade a-b7 must be present. child-pugh status should be determined based on clinical findings and laboratory data during the screening period (appendix e). subjects on anti-coagulants are to receive 1 point for their inr status, as they are presumed to have a <1.7 baseline pt/inr.", or histologically proven high-grade glioma who have failed (pd and/or side effects) treatment with radiotherapy ± temozolomide.
boolean
C0854889 (UMLS CUI [1])
C1377610 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C4324656 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1514461 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0220633 (UMLS CUI [6,1])
C1522484 (UMLS CUI [6,2])
C2239176 (UMLS CUI [7])
C1516119 (UMLS CUI [8,1])
C0231175 (UMLS CUI [8,2])
C0242656 (UMLS CUI [9,1])
C0034571 (UMLS CUI [9,2])
C0449438 (UMLS CUI [10,1])
C0439686 (UMLS CUI [10,2])
C4050412 (UMLS CUI [10,3])
C0150457 (UMLS CUI [11])
C0525032 (UMLS CUI [12,1])
C0449438 (UMLS CUI [12,2])
C0017638 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0076080 (UMLS CUI [14,1])
C0231175 (UMLS CUI [14,2])
ASS1 Deficiency Tissue specimen Immunohistochemistry
Item
2. ass1 deficiency (defined as ≤50% ass expression) demonstrated on tissue specimen (cytospin samples are acceptable) by immunohistochemistry (ihc). for subjects previously treated with chemotherapy, this specimen may have been obtained before that chemotherapy. a new tissue specimen obtained after most recent chemotherapy is not required. thus ass1 deficiency is required for entrance into the study. if tissue is not available to determine ass1 deficiency, then tissue must be obtained by biopsy to determine ass1 status.
boolean
C4527366 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
Measurable Disease
Item
3. measurable disease as assessed by modified recist for mpm and by recist 1.1 criteria for peritoneal mesothelioma, nsclc, uveal melanoma, hcc and glioma (appendices a and b).
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0 - 1 (appendix c).
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
5. predicted life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Exception Intent Palliative | Targeted Therapy | Immunotherapy | Exception Immunotherapy Uveal melanoma
Item
1. radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment.
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C1285530 (UMLS CUI [2,3])
C2985566 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0021083 (UMLS CUI [5,2])
C0220633 (UMLS CUI [5,3])
Manifestations Toxic Due to Prior Therapy
Item
2. ongoing toxic manifestations of previous treatments.
boolean
C1280464 (UMLS CUI [1,1])
C1407029 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
Metastatic malignant neoplasm to brain Symptomatic | Secondary malignant neoplasm of spinal cord Symptomatic | Patient's condition stable Post Therapeutic radiology procedure | Patient's condition stable Post Operative Surgical Procedures
Item
3. symptomatic brain or spinal cord metastases (patients must be stable for > 3 months post radiotherapy or surgery) for subjects with mesothelioma, nsclc, uveal melanoma excludes subjects with hcc or glioma).
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0347016 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1282982 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1282982 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
Thoracic Surgical Procedure Major | Operation on abdominal region Major | Recovery Lacking
Item
4. major thoracic or abdominal surgery from which the patient has not yet recovered.
boolean
C0524832 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0198482 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C2004454 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Communicable Disease Serious | Requirement Antibiotics Intravenous | Communicable Disease Requirement Intravenous therapy
Item
5. serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior to the first dose of study treatment.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0455142 (UMLS CUI [3,3])
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