{
"info": {
"nct_id": "NCT00338182",
"official_title": "A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a 2-hour or 48-hour Intravenous Infusions in Patients With Advanced Solid Malignancies",
"inclusion_criteria": "* Histological or cytological confirmation of a solid, malignant tumour\n* At least one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 130 Years",
"exclusion_criteria": "* Participation in an investigational drug study within the 21 days prior to therapy or those who have not recovered from the effects of an investigational study drug\n* Recent major surgery within 4 weeks prior to entry into the study",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histological or cytological confirmation of a solid, malignant tumour",
"criterions": [
{
"exact_snippets": "Histological or cytological confirmation of a solid, malignant tumour",
"criterion": "solid, malignant tumour",
"requirement": {
"requirement_type": "confirmation",
"expected_value": [
"histological",
"cytological"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histological or cytological confirmation of a solid, malignant tumour",
"criterion": "solid, malignant tumour",
"requirement": {
"requirement_type": "confirmation",
"expected_value": [
"histological",
"cytological"
]
}
}
]
}
},
{
"identified_line": {
"line": "* At least one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.",
"criterions": [
{
"exact_snippets": "At least one measurable or non-measurable site of disease",
"criterion": "site of disease",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "site"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least one measurable or non-measurable site of disease",
"criterion": "site of disease",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "site"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 130 Years",
"criterions": [
{
"exact_snippets": "maximum age of 130 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 130,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 130 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 130,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Participation in an investigational drug study within the 21 days prior to therapy or those who have not recovered from the effects of an investigational study drug",
"criterions": [
{
"exact_snippets": "Participation in an investigational drug study within the 21 days prior to therapy",
"criterion": "participation in investigational drug study",
"requirement": {
"requirement_type": "time since participation",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "days"
}
}
},
{
"exact_snippets": "those who have not recovered from the effects of an investigational study drug",
"criterion": "recovery from effects of investigational study drug",
"requirement": {
"requirement_type": "recovery",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Participation in an investigational drug study within the 21 days prior to therapy",
"criterion": "participation in investigational drug study",
"requirement": {
"requirement_type": "time since participation",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "days"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "those who have not recovered from the effects of an investigational study drug",
"criterion": "recovery from effects of investigational study drug",
"requirement": {
"requirement_type": "recovery",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Recent major surgery within 4 weeks prior to entry into the study",
"criterions": [
{
"exact_snippets": "Recent major surgery within 4 weeks prior to entry into the study",
"criterion": "major surgery",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Recent major surgery within 4 weeks prior to entry into the study",
"criterion": "major surgery",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}