ID

41409

Descrição

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02240238

Link

https://clinicaltrials.gov/show/NCT02240238

Palavras-chave

Versões (3)
  1. 19/01/2019 19/01/2019 -
  2. 28/09/2020 28/09/2020 -
  3. 01/10/2020 01/10/2020 -
Titular dos direitos

see on clinicaltrials.gov

Transferido a

1 de outubro de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Solid Tumors, NSCLC, Biliary and Bladder Cancer NCT02240238

Inglês

Eligibility Solid Tumors, NSCLC, Biliary and Bladder Cancer NCT02240238

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
(part 1 only) have a histologically or cytologically confirmed diagnosis of advanced solid tumor that has relapsed or is refractory to standard curative or palliative therapy or has a contraindication to standard therapy.
Descrição

Histologically or cytologically confirmed advanced solid neoplasms, recurrent, unresponsive to treatment or with contraindication to standard therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0277556
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C0280100
UMLS CUI [3,2]
C1301624
UMLS CUI [3,3]
C1442989
UMLS CUI [3,4]
C0087111
UMLS CUI [4,1]
C0280100
UMLS CUI [4,2]
C1300072
UMLS CUI [5,1]
C0280100
UMLS CUI [5,2]
C0449575
UMLS CUI [6,1]
C0280100
UMLS CUI [6,2]
C1265900
(part 2 only) have histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc and have received 1 or 2 lines of prior chemotherapy or targeted therapy for stage iiib or iv nsclc (second- or third-line).
Descrição

Histologically or cytologically confirmed NSCLC stage iiiv or iv after prior chemotherapy or targeted therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0449575
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C1265900
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C1300072
UMLS CUI [4,1]
C0007131
UMLS CUI [4,2]
C1514457
UMLS CUI [5,1]
C0007131
UMLS CUI [5,2]
C1514463
UMLS CUI [5,3]
C2985566
have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1.
Descrição

Measurable Disease (recist)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1709926
UMLS CUI [2]
C1513041
eastern cooperative oncology group (ecog) performance status of 0 to 1
Descrição

Ecog performance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
have adequate bone marrow reserve, liver function, and renal function
Descrição

Adequate bone marrow reserve, liver and renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received prior platinum therapy in the past 3 months
Descrição

Recent platinum therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3536920
UMLS CUI [1,2]
C0332185
have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
Descrição

Recent therapy with or refractory to cisplatin and gemcitabine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0338265
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0338265
UMLS CUI [2,2]
C0205269
unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment
Descrição

Unresolved toxicity from radio-, chemo- or other targeted therapy like investigational therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0443342
UMLS CUI [1,3]
C0279134
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0443342
UMLS CUI [2,3]
C1514457
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0443342
UMLS CUI [3,3]
C1514463
UMLS CUI [3,4]
C2985566
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0443342
UMLS CUI [4,3]
C1514463
UMLS CUI [4,4]
C0949266
pregnant or breast feeding
Descrição

Pregnant, breast feeding

Tipo de dados

boolean

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

Eligibility Solid Tumors, NSCLC, Biliary and Bladder Cancer NCT02240238

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Histologically or cytologically confirmed advanced solid neoplasms, recurrent, unresponsive to treatment or with contraindication to standard therapy
Item
(part 1 only) have a histologically or cytologically confirmed diagnosis of advanced solid tumor that has relapsed or is refractory to standard curative or palliative therapy or has a contraindication to standard therapy.
boolean
C0280100 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0280100 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C1442989 (UMLS CUI [3,3])
C0087111 (UMLS CUI [3,4])
C0280100 (UMLS CUI [4,1])
C1300072 (UMLS CUI [4,2])
C0280100 (UMLS CUI [5,1])
C0449575 (UMLS CUI [5,2])
C0280100 (UMLS CUI [6,1])
C1265900 (UMLS CUI [6,2])
Histologically or cytologically confirmed NSCLC stage iiiv or iv after prior chemotherapy or targeted therapy
Item
(part 2 only) have histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc and have received 1 or 2 lines of prior chemotherapy or targeted therapy for stage iiib or iv nsclc (second- or third-line).
boolean
C0007131 (UMLS CUI [1,1])
C0449575 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C1265900 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3,1])
C1300072 (UMLS CUI [3,2])
C0007131 (UMLS CUI [4,1])
C1514457 (UMLS CUI [4,2])
C0007131 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
C2985566 (UMLS CUI [5,3])
Measurable Disease (recist)
Item
have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1.
boolean
C1709926 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Ecog performance
Item
eastern cooperative oncology group (ecog) performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Adequate bone marrow reserve, liver and renal function
Item
have adequate bone marrow reserve, liver function, and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Recent platinum therapy
Item
have received prior platinum therapy in the past 3 months
boolean
C3536920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent therapy with or refractory to cisplatin and gemcitabine
Item
have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
boolean
C0338265 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0338265 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Unresolved toxicity from radio-, chemo- or other targeted therapy like investigational therapy
Item
unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment
boolean
C0600688 (UMLS CUI [1,1])
C0443342 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0443342 (UMLS CUI [2,2])
C1514457 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0443342 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
C2985566 (UMLS CUI [3,4])
C0600688 (UMLS CUI [4,1])
C0443342 (UMLS CUI [4,2])
C1514463 (UMLS CUI [4,3])
C0949266 (UMLS CUI [4,4])
Pregnant, breast feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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