ID

41171

Beschreibung

Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01526928

Link

https://clinicaltrials.gov/show/NCT01526928

Stichworte

Versionen (1)
  1. 04.07.20 04.07.20 -
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See clinicaltrials.gov

Hochgeladen am

4. Juli 2020

DOI

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Creative Commons BY-NC 4.0
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Eligibility Locally Advanced or Metastatic Non-small Cell Lung Cancer. NCT01526928

Englisch

Eligibility Locally Advanced or Metastatic Non-small Cell Lung Cancer. NCT01526928

1 Formulare  
Criteria
Beschreibung

Criteria

all patients must meet the following inclusion criteria:
Beschreibung

Inclusion criteria All Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1550543
1. metastatic or unresectable locally advanced nsclc
Beschreibung

Metastatic non-small cell lung cancer | Locally Advanced Lung Non-Small Cell Carcinoma Unresectable

Datentyp

boolean

Alias
UMLS CUI [1]
C0278987
UMLS CUI [2,1]
C5205550
UMLS CUI [2,2]
C1519810
2. evidence of a tumor with one or more egfr mutations excluding exon 20 insertion
Beschreibung

Neoplasm | EGFR mutation Quantity | Exception Exon 20 insertion

Datentyp

boolean

Alias
UMLS CUI [1]
C0027651
UMLS CUI [2,1]
C3266992
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2733661
3. biopsy of either primary or metastatic tumor tissue within 60 days of dosing
Beschreibung

Biopsy Tumor tissue sample | Biopsy Tumor tissue sample metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0475358
UMLS CUI [2,3]
C1522484
4. eastern cooperative oncology group (ecog) performance status of 0 to 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
5. minimum age of 18 years
Beschreibung

Age Minimum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1524031
6. adequate hematological and biological function
Beschreibung

Hematologic function | Biological function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C3714634
7. written consent on an irb/iec-approved informed consent form (icf) prior to any study-specific evaluation
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
phase 2 cohorts must also meet the following inclusion criteria:
Beschreibung

Phase Number Cohort | Inclusion criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710475
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0599755
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C1550543
disease progression confirmed by radiologic assessment while on treatment with egfr-
Beschreibung

Disease Progression | EGFR Tyrosine Kinase inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C1443775
tki or
Beschreibung

ID.11

Datentyp

boolean

disease progression confirmed by radiologic assessment while on treatment with the first single agent egfr tki and
Beschreibung

Disease Progression | EGFR Tyrosine Kinase inhibitor Single Agent Therapy First

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1443775
UMLS CUI [2,2]
C4763675
UMLS CUI [2,3]
C0205435
documented evidence of t790m mutation in egfr following disease progression on the first single agent egfr tki.
Beschreibung

EGFR T790M Mutation | Status post Disease Progression |

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274192
UMLS CUI [1,2]
C0026882
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0242656
measureable disease according to recist version 1.1
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
exclusion criteria -
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
any of the following criteria will exclude patients from study participation:
Beschreibung

Exclusion Criteria Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
1. documented evidence of an exon 20 insertion activating mutation in the egfr gene
Beschreibung

Exon 20 insertion EGFR Activating Mutation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2733661
UMLS CUI [1,2]
C2984891
2. active second malignancy
Beschreibung

Second Primary Cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0751623
3. known pre-existing interstitial lung disease
Beschreibung

Interstitial Lung Disease Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C2347662
4. patients with leptomeningeal carcinomatosis are excluded. other cns metastases are only permitted if treated, asymptomatic and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).
Beschreibung

Meningeal Carcinomatosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0220654
5. treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib
Beschreibung

Illicit medication use

Datentyp

boolean

Alias
UMLS CUI [1]
C0281875
6. patients who are currently receiving treatment with any medications that have the potential to prolong the qt interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib
Beschreibung

Pharmaceutical Preparations Causing Prolonged QT interval

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
7. prior treatment with rociletinib or other drugs that target t790m positive mutant egfr with sparing of wild type egfr
Beschreibung

Rociletinib Previous | Targeted Therapy EGFR T790M

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4045493
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C3274192
8. certain cardiac abnormalities or history
Beschreibung

Cardiac abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0018798
9. non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib
Beschreibung

Recent surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C2169607
10. females who are pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib
Beschreibung

Females & males of reproductive potential Contraceptive methods Refused

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1705116
12. presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
Beschreibung

Systemic disease Serious | Systemic disease Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0443343
13. any other reason the investigator considers the patient should not participate in the study
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Locally Advanced or Metastatic Non-small Cell Lung Cancer. NCT01526928

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion criteria All Fulfill
Item
all patients must meet the following inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Metastatic non-small cell lung cancer | Locally Advanced Lung Non-Small Cell Carcinoma Unresectable
Item
1. metastatic or unresectable locally advanced nsclc
boolean
C0278987 (UMLS CUI [1])
C5205550 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
Neoplasm | EGFR mutation Quantity | Exception Exon 20 insertion
Item
2. evidence of a tumor with one or more egfr mutations excluding exon 20 insertion
boolean
C0027651 (UMLS CUI [1])
C3266992 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C2733661 (UMLS CUI [3,2])
Biopsy Tumor tissue sample | Biopsy Tumor tissue sample metastatic
Item
3. biopsy of either primary or metastatic tumor tissue within 60 days of dosing
boolean
C0005558 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C0475358 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Age Minimum
Item
5. minimum age of 18 years
boolean
C0001779 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Hematologic function | Biological function
Item
6. adequate hematological and biological function
boolean
C0221130 (UMLS CUI [1])
C3714634 (UMLS CUI [2])
Informed Consent
Item
7. written consent on an irb/iec-approved informed consent form (icf) prior to any study-specific evaluation
boolean
C0021430 (UMLS CUI [1])
Phase Number Cohort | Inclusion criteria Fulfill
Item
phase 2 cohorts must also meet the following inclusion criteria:
boolean
C1710475 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0599755 (UMLS CUI [1,3])
C1512693 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Disease Progression | EGFR Tyrosine Kinase inhibitor
Item
disease progression confirmed by radiologic assessment while on treatment with egfr-
boolean
C0242656 (UMLS CUI [1])
C1443775 (UMLS CUI [2])
ID.11
Item
tki or
boolean
Disease Progression | EGFR Tyrosine Kinase inhibitor Single Agent Therapy First
Item
disease progression confirmed by radiologic assessment while on treatment with the first single agent egfr tki and
boolean
C0242656 (UMLS CUI [1])
C1443775 (UMLS CUI [2,1])
C4763675 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
EGFR T790M Mutation | Status post Disease Progression |
Item
documented evidence of t790m mutation in egfr following disease progression on the first single agent egfr tki.
boolean
C3274192 (UMLS CUI [1,1])
C0026882 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Measurable Disease
Item
measureable disease according to recist version 1.1
boolean
C1513041 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria -
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria Any
Item
any of the following criteria will exclude patients from study participation:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Exon 20 insertion EGFR Activating Mutation
Item
1. documented evidence of an exon 20 insertion activating mutation in the egfr gene
boolean
C2733661 (UMLS CUI [1,1])
C2984891 (UMLS CUI [1,2])
Second Primary Cancer
Item
2. active second malignancy
boolean
C0751623 (UMLS CUI [1])
Interstitial Lung Disease Pre-existing
Item
3. known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Meningeal Carcinomatosis
Item
4. patients with leptomeningeal carcinomatosis are excluded. other cns metastases are only permitted if treated, asymptomatic and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).
boolean
C0220654 (UMLS CUI [1])
Illicit medication use
Item
5. treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib
boolean
C0281875 (UMLS CUI [1])
Pharmaceutical Preparations Causing Prolonged QT interval
Item
6. patients who are currently receiving treatment with any medications that have the potential to prolong the qt interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
Rociletinib Previous | Targeted Therapy EGFR T790M
Item
7. prior treatment with rociletinib or other drugs that target t790m positive mutant egfr with sparing of wild type egfr
boolean
C4045493 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C3274192 (UMLS CUI [2,2])
Cardiac abnormalities
Item
8. certain cardiac abnormalities or history
boolean
C0018798 (UMLS CUI [1])
Recent surgery
Item
9. non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib
boolean
C2169607 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
10. females who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Refused
Item
11. refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
Systemic disease Serious | Systemic disease Unstable
Item
12. presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
boolean
C0442893 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Study Subject Participation Status Inappropriate
Item
13. any other reason the investigator considers the patient should not participate in the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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