ID

23652

Descrição

Responsible Party: Millennium Pharmaceuticals, Inc. ClinicalTrials.gov Identifier: NCT02038647 History of Changes Other Study ID Numbers: C14018 2013-003713-18 ( EudraCT Number ) U1111-1154-9805 ( Registry Identifier: WHO ) DRKS00007849 ( Registry Identifier: DRKS ) Study First Received: December 4, 2013 Last Updated: March 30, 2017 Phase 2 Study of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02038647

Link

https://clinicaltrials.gov/ct2/show/NCT02038647

Palavras-chave

Versões (1)
  1. 10/07/2017 10/07/2017 -
Transferido a

10 de julho de 2017

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Licença

Creative Commons BY 4.0
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Eligibility Small Cell Lung Cancer NCT02038647 DRKS00007849

Inglês

Eligibility Small Cell Lung Cancer NCT02038647 DRKS00007849

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Male or female participants ≥ 18 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. Have a pathologically (histology or cytology) confirmed diagnosis of SCLC.
Descrição

Small Cell Lung Cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149925
3. Have received and progressed after a platinum-based standard chemotherapy regimen for first line treatment of SCLC, either limited stage (LS) or extensive stage (ES).
Descrição

Chemotherapy Regimen

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
4. Have measurable disease within ≤ 2 weeks before randomization. Clear radiographic evidence of disease progression after initial therapy should have been documented.
Descrição

Measurable disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (PS 0-1).
Descrição

ECOG Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
6. Participants with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the participant is off steroids or is on a stable dose of steroids. Participants should be without neurologic dysfunction that would confound the evaluation of neurological and/or other AEs.
Descrição

Brain metastases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Descrição

Control Group

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009932
1. Any prior therapy for second-line treatment of SCLC.
Descrição

Prior Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
2. Participants who relapsed ≥ 180 days after their response to first-line treatment.
Descrição

Relapse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0277556
3. Prior treatment with an Aurora A specific-targeted or pan-Aurora-targeted agent, including alisertib, or any other investigational agent.
Descrição

Investigational Drug

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
4. Prior treatment with paclitaxel or any other taxane agent.
Descrição

Paclitaxel

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0144576
5. Known hypersensitivity to Cremophor® EL, paclitaxel, or its components.
Descrição

Hypersensitivity to Paclitaxel

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0215136
6. Any comorbid condition or unresolved toxicity that would preclude administration of alisertib or weekly paclitaxel.
Descrição

Comorbidity, Toxicity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0013221
7. Prior history of ≥ Grade 2 neurotoxicity that is not resolved to ≤ Grade 1.
Descrição

Neurotoxicity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235032
8. Participants with symptomatic and/or progressive brain metastases or with carcinomatous meningitis.
Descrição

Brain metastases or carcinomatous meningitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0220654
9. Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of alisertib and during study conduct. Major prohibited enzyme inducers include: phenytoin, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentine, and St. John's wort.
Descrição

Enzyme inducers

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3819045
10. Inability to swallow alisertib or other orally administered medications.
Descrição

Ability to swallow

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0566355
11. Requirement for administration of proton pump inhibitor (PPI), H2 antagonist, or pancreatic enzymes.
Descrição

Proton pump inhibitor, H2 antagonist, or pancreatic enzymes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0358591
UMLS CUI [2]
C0019593
UMLS CUI [3]
C0920330
12. Diagnosed with or treated for another malignancy within 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease.
Descrição

Malignancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
13. Other severe acute or chronic medical or psychiatric condition(s) per protocol.
Descrição

Mental disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004936
14. History of myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, any ongoing cardiac arrhythmias of Grade > 2, thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy) within 6 months before receiving the first dose of study drug.
Descrição

Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
15. Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C.
Descrição

HIV, HBV, HCV

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
16. Surgery within 3 weeks (or 2 weeks for a minor surgery) before study enrollment and not fully recovered to baseline or to a stable clinical status
Descrição

Surgery

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543467
17. Participants who are pregnant, lactating, or do not agree to use effective methods of contraception during the study treatment period through 6 months after the last dose of study drug per protocol.
Descrição

Gynaecological Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
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Similar models

Eligibility Small Cell Lung Cancer NCT02038647 DRKS00007849

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
1. Male or female participants ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
Small Cell Lung Cancer
Item
2. Have a pathologically (histology or cytology) confirmed diagnosis of SCLC.
boolean
C0149925 (UMLS CUI [1])
Chemotherapy Regimen
Item
3. Have received and progressed after a platinum-based standard chemotherapy regimen for first line treatment of SCLC, either limited stage (LS) or extensive stage (ES).
boolean
C0392920 (UMLS CUI [1])
Measurable disease
Item
4. Have measurable disease within ≤ 2 weeks before randomization. Clear radiographic evidence of disease progression after initial therapy should have been documented.
boolean
C1513041 (UMLS CUI [1])
ECOG Performance Status
Item
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (PS 0-1).
boolean
C1520224 (UMLS CUI [1])
Brain metastases
Item
6. Participants with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the participant is off steroids or is on a stable dose of steroids. Participants should be without neurologic dysfunction that would confound the evaluation of neurological and/or other AEs.
boolean
C0220650 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Prior Therapy
Item
1. Any prior therapy for second-line treatment of SCLC.
boolean
C1514463 (UMLS CUI [1])
Relapse
Item
2. Participants who relapsed ≥ 180 days after their response to first-line treatment.
boolean
C0277556 (UMLS CUI [1])
Investigational Drug
Item
3. Prior treatment with an Aurora A specific-targeted or pan-Aurora-targeted agent, including alisertib, or any other investigational agent.
boolean
C0013230 (UMLS CUI [1])
Paclitaxel
Item
4. Prior treatment with paclitaxel or any other taxane agent.
boolean
C0144576 (UMLS CUI [1])
Hypersensitivity to Paclitaxel
Item
5. Known hypersensitivity to Cremophor® EL, paclitaxel, or its components.
boolean
C0020517 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
Comorbidity, Toxicity
Item
6. Any comorbid condition or unresolved toxicity that would preclude administration of alisertib or weekly paclitaxel.
boolean
C0009488 (UMLS CUI [1])
C0013221 (UMLS CUI [2])
Neurotoxicity
Item
7. Prior history of ≥ Grade 2 neurotoxicity that is not resolved to ≤ Grade 1.
boolean
C0235032 (UMLS CUI [1])
Brain metastases or carcinomatous meningitis
Item
8. Participants with symptomatic and/or progressive brain metastases or with carcinomatous meningitis.
boolean
C0220650 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Enzyme inducers
Item
9. Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of alisertib and during study conduct. Major prohibited enzyme inducers include: phenytoin, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentine, and St. John's wort.
boolean
C3819045 (UMLS CUI [1])
Ability to swallow
Item
10. Inability to swallow alisertib or other orally administered medications.
boolean
C0566355 (UMLS CUI [1])
Proton pump inhibitor, H2 antagonist, or pancreatic enzymes
Item
11. Requirement for administration of proton pump inhibitor (PPI), H2 antagonist, or pancreatic enzymes.
boolean
C0358591 (UMLS CUI [1])
C0019593 (UMLS CUI [2])
C0920330 (UMLS CUI [3])
Malignancy
Item
12. Diagnosed with or treated for another malignancy within 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease.
boolean
C0006826 (UMLS CUI [1])
Mental disorder
Item
13. Other severe acute or chronic medical or psychiatric condition(s) per protocol.
boolean
C0004936 (UMLS CUI [1])
Comorbidity
Item
14. History of myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, any ongoing cardiac arrhythmias of Grade > 2, thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy) within 6 months before receiving the first dose of study drug.
boolean
C0009488 (UMLS CUI [1])
HIV, HBV, HCV
Item
15. Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C.
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Surgery
Item
16. Surgery within 3 weeks (or 2 weeks for a minor surgery) before study enrollment and not fully recovered to baseline or to a stable clinical status
boolean
C0543467 (UMLS CUI [1])
Gynaecological Status
Item
17. Participants who are pregnant, lactating, or do not agree to use effective methods of contraception during the study treatment period through 6 months after the last dose of study drug per protocol.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
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