ID

23652

Beschreibung

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

Stichworte

Versionen (1)
  1. 10.07.17 10.07.17 -
Hochgeladen am

10. Juli 2017

DOI

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Eligibility Small Cell Lung Cancer NCT02038647 DRKS00007849

Englisch

Eligibility Small Cell Lung Cancer NCT02038647 DRKS00007849

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Small Cell Lung Cancer

Datentyp

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).
Beschreibung

Chemotherapy Regimen

Datentyp

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.
Beschreibung

Measurable disease

Datentyp

boolean

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

ECOG Performance Status

Datentyp

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.
Beschreibung

Brain metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

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

Prior Therapy

Datentyp

boolean

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

Relapse

Datentyp

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.
Beschreibung

Investigational Drug

Datentyp

boolean

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

Paclitaxel

Datentyp

boolean

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

Hypersensitivity to Paclitaxel

Datentyp

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.
Beschreibung

Comorbidity, Toxicity

Datentyp

boolean

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

Neurotoxicity

Datentyp

boolean

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

Brain metastases or carcinomatous meningitis

Datentyp

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.
Beschreibung

Enzyme inducers

Datentyp

boolean

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

Ability to swallow

Datentyp

boolean

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

Proton pump inhibitor, H2 antagonist, or pancreatic enzymes

Datentyp

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.
Beschreibung

Malignancy

Datentyp

boolean

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

Mental disorder

Datentyp

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.
Beschreibung

Comorbidity

Datentyp

boolean

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

HIV, HBV, HCV

Datentyp

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
Beschreibung

Surgery

Datentyp

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.
Beschreibung

Gynaecological Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
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Ähnliche Modelle

Eligibility Small Cell Lung Cancer NCT02038647 DRKS00007849

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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