ID

35475

Beschreibung

Phase 1 Trial To Evaluate mFOLFOX6 With Selinexor In Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02384850

Link

https://clinicaltrials.gov/show/NCT02384850

Stichworte

Versionen (1)
  1. 05.03.19 05.03.19 -
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See clinicaltrials.gov

Hochgeladen am

5. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasm NCT02384850

Englisch

Eligibility Colorectal Neoplasm NCT02384850

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage iv (uicc) disease (primary tumor may be present)
Beschreibung

Colorectal Carcinoma unresectable TNM clinical staging | Primary tumor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C3258246
UMLS CUI [2]
C0677930
2. patients who are feasible for treatment with folfox (prior adjuvant or palliative treatment is allowed)
Beschreibung

Patients Appropriate FOLFOX Regimen | Adjuvant therapy Previous allowed | Palliative treatment Previous allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0392943
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0030231
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0683607
3. ecog performance status ≤ 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
4. life expectancy > 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
5. age ≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. haematologic function as follows (5% deviation allowed):
Beschreibung

Hematologic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
anc ≥ 1.5 x 109/l
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥ 100 x109/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 9 g/dl or 5.59 mmol/l
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
7. adequate liver function as follows (10% deviation allowed)
Beschreibung

Liver function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
serum alanine transaminase (alt) ≤ 2.5 x uln (in case of liver metastases < 5 x uln)
Beschreibung

Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0494165
total bilirubin ≤ 1.5 x uln (patients with gilbert's syndrome total bilirubin
Beschreibung

Serum total bilirubin measurement | Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
≤2.5 x uln)
Beschreibung

ID.13

Datentyp

boolean

8. adequate renal function as follows (10% deviation allowed)
Beschreibung

Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
· creatinine ≤ 1.5 x uln
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
9. signed written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
10. women of child-bearing potential must have a negative pregnancy test
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; 2. treatment with any systemic anticancer therapy ≤ 3 weeks prior to cycle 1 day 1 3. uncontrolled active infection (hepatitis b and c infection are not exclusion criteria) and/or known hiv infection; 4. renal failure requiring haemodialysis or peritoneal dialysis; 5. patients who are pregnant or breast-feeding; 6. patients with significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea resulting in inability to swallow oral medications; 7. presence of symptomatic cns metastasis 8. unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery, in particular oxaliplatin-induced peripheral neuropathy > grade 1.
Beschreibung

Disease Controlled | Therapeutic procedure Appropriate | Cancer treatment Systemic | Communicable Disease Uncontrolled | HIV Infection | Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis | Pregnancy | Breast Feeding | Gastrointestinal Diseases | Gastrointestinal obstruction | Malabsorption | Vomiting Uncontrolled | Diarrhea Uncontrolled | Lacking Able to swallow Oral medication | CNS metastases Symptomatic | Toxicity Due to Cancer treatment | Resolution Lacking | Operative Surgical Procedure Recovery Incomplete | Peripheral Neuropathy Oxaliplatin induced CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C2911690
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1548787
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C0205373
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0019693
UMLS CUI [6,1]
C0035078
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0019004
UMLS CUI [7,1]
C0035078
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0031139
UMLS CUI [8]
C0032961
UMLS CUI [9]
C0006147
UMLS CUI [10]
C0017178
UMLS CUI [11]
C0236124
UMLS CUI [12]
C0024523
UMLS CUI [13,1]
C0042963
UMLS CUI [13,2]
C0205318
UMLS CUI [14,1]
C0011991
UMLS CUI [14,2]
C0205318
UMLS CUI [15,1]
C0332268
UMLS CUI [15,2]
C2712086
UMLS CUI [15,3]
C0175795
UMLS CUI [16,1]
C0686377
UMLS CUI [16,2]
C0231220
UMLS CUI [17,1]
C0600688
UMLS CUI [17,2]
C0678226
UMLS CUI [17,3]
C0920425
UMLS CUI [18,1]
C1514893
UMLS CUI [18,2]
C0332268
UMLS CUI [19,1]
C0543467
UMLS CUI [19,2]
C2004454
UMLS CUI [19,3]
C0205257
UMLS CUI [20,1]
C0031117
UMLS CUI [20,2]
C0069717
UMLS CUI [20,3]
C0458082
UMLS CUI [20,4]
C1516728
9. any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
Beschreibung

Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral arterial bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0190961
UMLS CUI [6]
C0742758
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0007787
UMLS CUI [9]
C0034065
UMLS CUI [10]
C0149871
UMLS CUI [11]
C0040038
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Ähnliche Modelle

Eligibility Colorectal Neoplasm NCT02384850

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma unresectable TNM clinical staging | Primary tumor
Item
1. patients with histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage iv (uicc) disease (primary tumor may be present)
boolean
C0009402 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0677930 (UMLS CUI [2])
Patients Appropriate FOLFOX Regimen | Adjuvant therapy Previous allowed | Palliative treatment Previous allowed
Item
2. patients who are feasible for treatment with folfox (prior adjuvant or palliative treatment is allowed)
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0392943 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0030231 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
ECOG performance status
Item
3. ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
5. age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Hematologic function
Item
6. haematologic function as follows (5% deviation allowed):
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count
Item
anc ≥ 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥ 100 x109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 9 g/dl or 5.59 mmol/l
boolean
C0518015 (UMLS CUI [1])
Liver function
Item
7. adequate liver function as follows (10% deviation allowed)
boolean
C0232741 (UMLS CUI [1])
Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
serum alanine transaminase (alt) ≤ 2.5 x uln (in case of liver metastases < 5 x uln)
boolean
C0201836 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Serum total bilirubin measurement | Gilbert Disease
Item
total bilirubin ≤ 1.5 x uln (patients with gilbert's syndrome total bilirubin
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
ID.13
Item
≤2.5 x uln)
boolean
Renal function
Item
8. adequate renal function as follows (10% deviation allowed)
boolean
C0232804 (UMLS CUI [1])
Creatinine measurement, serum
Item
· creatinine ≤ 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
9. signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
10. women of child-bearing potential must have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease Controlled | Therapeutic procedure Appropriate | Cancer treatment Systemic | Communicable Disease Uncontrolled | HIV Infection | Kidney Failure Requirement Hemodialysis | Kidney Failure Requirement Peritoneal Dialysis | Pregnancy | Breast Feeding | Gastrointestinal Diseases | Gastrointestinal obstruction | Malabsorption | Vomiting Uncontrolled | Diarrhea Uncontrolled | Lacking Able to swallow Oral medication | CNS metastases Symptomatic | Toxicity Due to Cancer treatment | Resolution Lacking | Operative Surgical Procedure Recovery Incomplete | Peripheral Neuropathy Oxaliplatin induced CTCAE Grades
Item
adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; 2. treatment with any systemic anticancer therapy ≤ 3 weeks prior to cycle 1 day 1 3. uncontrolled active infection (hepatitis b and c infection are not exclusion criteria) and/or known hiv infection; 4. renal failure requiring haemodialysis or peritoneal dialysis; 5. patients who are pregnant or breast-feeding; 6. patients with significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea resulting in inability to swallow oral medications; 7. presence of symptomatic cns metastasis 8. unresolved toxicity from previous anti-cancer therapy or incomplete recovery from surgery, in particular oxaliplatin-induced peripheral neuropathy > grade 1.
boolean
C2911690 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
C0035078 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0019004 (UMLS CUI [6,3])
C0035078 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0031139 (UMLS CUI [7,3])
C0032961 (UMLS CUI [8])
C0006147 (UMLS CUI [9])
C0017178 (UMLS CUI [10])
C0236124 (UMLS CUI [11])
C0024523 (UMLS CUI [12])
C0042963 (UMLS CUI [13,1])
C0205318 (UMLS CUI [13,2])
C0011991 (UMLS CUI [14,1])
C0205318 (UMLS CUI [14,2])
C0332268 (UMLS CUI [15,1])
C2712086 (UMLS CUI [15,2])
C0175795 (UMLS CUI [15,3])
C0686377 (UMLS CUI [16,1])
C0231220 (UMLS CUI [16,2])
C0600688 (UMLS CUI [17,1])
C0678226 (UMLS CUI [17,2])
C0920425 (UMLS CUI [17,3])
C1514893 (UMLS CUI [18,1])
C0332268 (UMLS CUI [18,2])
C0543467 (UMLS CUI [19,1])
C2004454 (UMLS CUI [19,2])
C0205257 (UMLS CUI [19,3])
C0031117 (UMLS CUI [20,1])
C0069717 (UMLS CUI [20,2])
C0458082 (UMLS CUI [20,3])
C1516728 (UMLS CUI [20,4])
Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral arterial bypass | Symptomatic congestive heart failure | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism
Item
9. any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
boolean
C0027051 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0190961 (UMLS CUI [5])
C0742758 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
C0034065 (UMLS CUI [9])
C0149871 (UMLS CUI [10])
C0040038 (UMLS CUI [11])
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