ID

38485

Beskrivning

Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT01078649

Länk

https://clinicaltrials.gov/show/NCT01078649

Nyckelord

Versioner (1)
  1. 2019-10-22 2019-10-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Cancer NCT01078649

Engelsk

Eligibility Cancer NCT01078649

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01078649
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed solid tumor or lymphoma;
Beskrivning

Solid Neoplasm | Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0280100
UMLS CUI [2]
C0024299
locally advanced or metastatic disease for which no life prolonging therapy is available and no standard therapy is judged appropriate by the investigator;
Beskrivning

Advanced disease Locally | Neoplasm Metastasis | Prolongation of Life Therapy Unavailable | Standard of Care Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0023677
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0686905
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C1548788
eastern cooperative oncology group performance status ≤ 1;
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic function as indicated by, anc ≥ 1,500/mm3, hgb >9.0 g/dl, platelet count ≥ 100,000/mm3
Beskrivning

Hematologic function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
adequate renal and liver function as indicated by serum creatinine ≤ 1.0 x uln or creatinine clearance of > 60 cc/min, serum albumin ≥ 3.0 gm/dl, total bilirubin < 1.0 x uln, ast and alt ≤ 2.5 x uln ; alkaline phosphatase ≤2.5 x uln
Beskrivning

Renal function | Liver function | Creatinine measurement, serum | Creatinine clearance measurement | Serum albumin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0373595
UMLS CUI [5]
C0523465
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201850
negative hepatitis b and hepatitis c testing;
Beskrivning

Hepatitis B test negative | Hepatitis C test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C1611173
UMLS CUI [2]
C1619717
qtc interval ≤450ms.
Beskrivning

QTc interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0489625
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. patients who have received prior radiotherapy must have discontinued steroids for 14 days prior to study entry and be clinically stable;
Beskrivning

Therapeutic radiology procedure | Radiotherapy to thorax | Prior radiation therapy | Steroids To be stopped

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C4038705
UMLS CUI [3]
C0279134
UMLS CUI [4,1]
C0038317
UMLS CUI [4,2]
C1272691
not recovered to ≤ grade 1 toxicity from prior radiotherapy or chemotherapy agents;
Beskrivning

Toxicity Due to Prior radiation therapy | Toxicity Due to Prior Chemotherapy | Recovery Lacking | Toxicity CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0279134
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1514457
UMLS CUI [3,1]
C2004454
UMLS CUI [3,2]
C0332268
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C1516728
use or requirement for use of aspirin or aspirin containing products with >81 mg of aspirin per day;
Beskrivning

Use aspirin | Requirement Use aspirin | Pharmaceutical Preparations Containing Aspirin | Aspirin U/day

Datatyp

boolean

Alias
UMLS CUI [1]
C1388856
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1388856
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C0004057
UMLS CUI [4,1]
C0004057
UMLS CUI [4,2]
C0456683
history of gastrointestinal bleeding within 1 year;
Beskrivning

Gastrointestinal Hemorrhage

Datatyp

boolean

Alias
UMLS CUI [1]
C0017181
history of diabetes mellitus requiring treatment with oral agents or insulin;
Beskrivning

Diabetes Mellitus Requirement Oral medication | Diabetes Mellitus Requirement Insulin regime

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0175795
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0557978
active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation;
Beskrivning

Rheumatoid Arthritis | Inflammatory Bowel Disease | Chronic infectious disease | Disease Associated with Chronic inflammation | Condition Associated with Chronic inflammation

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0151317
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0021376
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0021376
known or suspected wilson's disease, or other conditions that affect copper accumulation or regulation;
Beskrivning

Wilson's disease | Wilson's disease Suspected | Condition Affecting Copper accumulation | Condition Affecting Copper Regulation

Datatyp

boolean

Alias
UMLS CUI [1]
C0019202
UMLS CUI [2,1]
C0019202
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C4227688
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0009968
UMLS CUI [4,4]
C1327622
prior treatment with iap inhibitors.
Beskrivning

Apoptosis Inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C1332320
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Similar models

Eligibility Cancer NCT01078649

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01078649
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Solid Neoplasm | Lymphoma
Item
histologically confirmed solid tumor or lymphoma;
boolean
C0280100 (UMLS CUI [1])
C0024299 (UMLS CUI [2])
Advanced disease Locally | Neoplasm Metastasis | Prolongation of Life Therapy Unavailable | Standard of Care Inappropriate
Item
locally advanced or metastatic disease for which no life prolonging therapy is available and no standard therapy is judged appropriate by the investigator;
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0023677 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0686905 (UMLS CUI [3,3])
C2936643 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group performance status ≤ 1;
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
adequate hematologic function as indicated by, anc ≥ 1,500/mm3, hgb >9.0 g/dl, platelet count ≥ 100,000/mm3
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Renal function | Liver function | Creatinine measurement, serum | Creatinine clearance measurement | Serum albumin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
adequate renal and liver function as indicated by serum creatinine ≤ 1.0 x uln or creatinine clearance of > 60 cc/min, serum albumin ≥ 3.0 gm/dl, total bilirubin < 1.0 x uln, ast and alt ≤ 2.5 x uln ; alkaline phosphatase ≤2.5 x uln
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
C0523465 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201850 (UMLS CUI [9])
Hepatitis B test negative | Hepatitis C test negative
Item
negative hepatitis b and hepatitis c testing;
boolean
C1611173 (UMLS CUI [1])
C1619717 (UMLS CUI [2])
QTc interval
Item
qtc interval ≤450ms.
boolean
C0489625 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Radiotherapy to thorax | Prior radiation therapy | Steroids To be stopped
Item
radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. patients who have received prior radiotherapy must have discontinued steroids for 14 days prior to study entry and be clinically stable;
boolean
C1522449 (UMLS CUI [1])
C4038705 (UMLS CUI [2])
C0279134 (UMLS CUI [3])
C0038317 (UMLS CUI [4,1])
C1272691 (UMLS CUI [4,2])
Toxicity Due to Prior radiation therapy | Toxicity Due to Prior Chemotherapy | Recovery Lacking | Toxicity CTCAE Grades
Item
not recovered to ≤ grade 1 toxicity from prior radiotherapy or chemotherapy agents;
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1514457 (UMLS CUI [2,3])
C2004454 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
Use aspirin | Requirement Use aspirin | Pharmaceutical Preparations Containing Aspirin | Aspirin U/day
Item
use or requirement for use of aspirin or aspirin containing products with >81 mg of aspirin per day;
boolean
C1388856 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C1388856 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0004057 (UMLS CUI [3,3])
C0004057 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
Gastrointestinal Hemorrhage
Item
history of gastrointestinal bleeding within 1 year;
boolean
C0017181 (UMLS CUI [1])
Diabetes Mellitus Requirement Oral medication | Diabetes Mellitus Requirement Insulin regime
Item
history of diabetes mellitus requiring treatment with oral agents or insulin;
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0557978 (UMLS CUI [2,3])
Rheumatoid Arthritis | Inflammatory Bowel Disease | Chronic infectious disease | Disease Associated with Chronic inflammation | Condition Associated with Chronic inflammation
Item
active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation;
boolean
C0003873 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0151317 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0021376 (UMLS CUI [4,3])
C0348080 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0021376 (UMLS CUI [5,3])
Wilson's disease | Wilson's disease Suspected | Condition Affecting Copper accumulation | Condition Affecting Copper Regulation
Item
known or suspected wilson's disease, or other conditions that affect copper accumulation or regulation;
boolean
C0019202 (UMLS CUI [1])
C0019202 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C4227688 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0009968 (UMLS CUI [4,3])
C1327622 (UMLS CUI [4,4])
Apoptosis Inhibitor
Item
prior treatment with iap inhibitors.
boolean
C1332320 (UMLS CUI [1])
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