{
"info": {
"nct_id": "NCT00256191",
"official_title": "A Phase 1, Open-Label, Q21 Day Dose Escalation, Multi-Center Study of TPI 287 in Patients With Advanced Malignancies",
"inclusion_criteria": "Patients must be/have:\n\n* Histological evidence of malignancy\n* Advanced solid tumors that have recurred or progressed following standard therapy\n* Failed one prior therapy or have no standard therapy available\n* Ambulatory with ECOG of 0-1 and estimated life expectancy of > 3 months\n* If female, negative pregnancy test\n* If of childbearing years, agree to use birth control\n* If patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
"exclusion_criteria": "Patients will be excluded if they are or have had:\n\n* Prior radiation within 4 weeks\n* Active medical condition or organ disease which may compromise safety or interfere with the study\n* Clinically significant cardiac co-morbidities or pulmonary impairment\n* Concomitant therapy needs\n* Treated with any investigational drugs within 30 days\n* Tumors involve major artery or vein\n* Prior or concurrent central nervous system (CNS) disease\n* Less than 4 weeks since major surgery\n* Known to be positive for HIV, hepatitis B or C\n* Concurrent use of aspirin\n* Use of thrombolytic agents\n* Uncontrolled hypertension\n* Grade II-IV peripheral vascular disease\n* Pregnant or lactating\n* Prior allergic history to compounds of similar chemical composition\n* Inpatients\n* Grade II-IV peripheral neuropathy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histological evidence of malignancy",
"criterions": [
{
"exact_snippets": "Histological evidence of malignancy",
"criterion": "malignancy",
"requirement": {
"requirement_type": "evidence",
"expected_value": "histological"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histological evidence of malignancy",
"criterion": "malignancy",
"requirement": {
"requirement_type": "evidence",
"expected_value": "histological"
}
}
]
}
},
{
"identified_line": {
"line": "* Advanced solid tumors that have recurred or progressed following standard therapy",
"criterions": [
{
"exact_snippets": "Advanced solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
},
{
"exact_snippets": "recurred",
"criterion": "tumor recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "progressed",
"criterion": "tumor progression",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "following standard therapy",
"criterion": "standard therapy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Advanced solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "stage",
"expected_value": "advanced"
}
},
{
"or_criteria": [
{
"exact_snippets": "recurred",
"criterion": "tumor recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "progressed",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
},
{
"exact_snippets": "following standard therapy",
"criterion": "standard therapy",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Failed one prior therapy or have no standard therapy available",
"criterions": [
{
"exact_snippets": "Failed one prior therapy",
"criterion": "prior therapy",
"requirement": {
"requirement_type": "status",
"expected_value": "failed"
}
},
{
"exact_snippets": "no standard therapy available",
"criterion": "standard therapy",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
},
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{
"exact_snippets": "Failed one prior therapy",
"criterion": "prior therapy",
"requirement": {
"requirement_type": "status",
"expected_value": "failed"
}
},
{
"exact_snippets": "no standard therapy available",
"criterion": "standard therapy",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Ambulatory with ECOG of 0-1 and estimated life expectancy of > 3 months",
"criterions": [
{
"exact_snippets": "Ambulatory",
"criterion": "ambulatory status",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "ECOG of 0-1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "estimated life expectancy of > 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ambulatory",
"criterion": "ambulatory status",
"requirement": {
"requirement_type": "status",
"expected_value": true
}
},
{
"exact_snippets": "ECOG of 0-1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
},
{
"exact_snippets": "estimated life expectancy of > 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* If female, negative pregnancy test",
"criterions": [
{
"exact_snippets": "If female, negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "If female, negative pregnancy test",
"criterion": "gender",
"requirement": {
"requirement_type": "identity",
"expected_value": "female"
}
},
"then_criteria": {
"exact_snippets": "If female, negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* If of childbearing years, agree to use birth control",
"criterions": [
{
"exact_snippets": "If of childbearing years",
"criterion": "childbearing years",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "agree to use birth control",
"criterion": "use of birth control",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "If of childbearing years",
"criterion": "childbearing years",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "agree to use birth control",
"criterion": "use of birth control",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* If patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month",
"criterions": [
{
"exact_snippets": "prior radiation therapy for brain metastases",
"criterion": "prior radiation therapy for brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "on steroids",
"criterion": "steroid use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must have been stable for 1 month",
"criterion": "stability",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
}
]
},
"logical_structure": {
"condition": {
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{
"exact_snippets": "prior radiation therapy for brain metastases",
"criterion": "prior radiation therapy for brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "on steroids",
"criterion": "steroid use",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"then_criteria": {
"exact_snippets": "must have been stable for 1 month",
"criterion": "stability",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
},
"else_criteria": null
}
},
{
"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": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
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{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 85 Years",
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{
"exact_snippets": "maximum age of 85 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 85,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 85 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
"operator": "<=",
"value": 85,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Patients must be/have:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Prior radiation within 4 weeks",
"criterions": [
{
"exact_snippets": "Prior radiation within 4 weeks",
"criterion": "prior radiation",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
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"exact_snippets": "Prior radiation within 4 weeks",
"criterion": "prior radiation",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
}
},
{
"identified_line": {
"line": "* Active medical condition or organ disease which may compromise safety or interfere with the study",
"criterions": [
{
"exact_snippets": "Active medical condition or organ disease",
"criterion": "medical condition or organ disease",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
},
{
"exact_snippets": "which may compromise safety",
"criterion": "safety",
"requirement": {
"requirement_type": "impact",
"expected_value": "compromise"
}
},
{
"exact_snippets": "interfere with the study",
"criterion": "study participation",
"requirement": {
"requirement_type": "impact",
"expected_value": "interfere"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Active medical condition or organ disease",
"criterion": "medical condition or organ disease",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
},
{
"exact_snippets": "which may compromise safety",
"criterion": "safety",
"requirement": {
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"expected_value": "compromise"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Active medical condition or organ disease",
"criterion": "medical condition or organ disease",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
},
{
"exact_snippets": "interfere with the study",
"criterion": "study participation",
"requirement": {
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"expected_value": "interfere"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Less than 4 weeks since major surgery",
"criterions": [
{
"exact_snippets": "Less than 4 weeks since major surgery",
"criterion": "time since major surgery",
"requirement": {
"requirement_type": "time",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "Less than 4 weeks since major surgery",
"criterion": "time since major surgery",
"requirement": {
"requirement_type": "time",
"expected_value": {
"operator": "<",
"value": 4,
"unit": "weeks"
}
}
}
}
},
{
"identified_line": {
"line": "* Concurrent use of aspirin",
"criterions": [
{
"exact_snippets": "Concurrent use of aspirin",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": true
}
}
]
},
"logical_structure": {
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"exact_snippets": "Concurrent use of aspirin",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "concurrent use",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Use of thrombolytic agents",
"criterions": [
{
"exact_snippets": "Use of thrombolytic agents",
"criterion": "thrombolytic agents",
"requirement": {
"requirement_type": "use",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Use of thrombolytic agents",
"criterion": "thrombolytic agents",
"requirement": {
"requirement_type": "use",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Uncontrolled hypertension",
"criterions": [
{
"exact_snippets": "Uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
}
}
},
{
"identified_line": {
"line": "* Grade II-IV peripheral vascular disease",
"criterions": [
{
"exact_snippets": "Grade II-IV peripheral vascular disease",
"criterion": "peripheral vascular disease",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "Grade"
},
{
"operator": "<=",
"value": 4,
"unit": "Grade"
}
]
}
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "Grade II-IV peripheral vascular disease",
"criterion": "peripheral vascular disease",
"requirement": {
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{
"operator": ">=",
"value": 2,
"unit": "Grade"
},
{
"operator": "<=",
"value": 4,
"unit": "Grade"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnant or lactating",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating",
"criterion": "lactation status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating",
"criterion": "lactation status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Prior allergic history to compounds of similar chemical composition",
"criterions": [
{
"exact_snippets": "Prior allergic history to compounds of similar chemical composition",
"criterion": "allergic history",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "Prior allergic history to compounds of similar chemical composition",
"criterion": "allergic history",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Inpatients",
"criterions": [
{
"exact_snippets": "Inpatients",
"criterion": "patient status",
"requirement": {
"requirement_type": "status",
"expected_value": "inpatient"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Inpatients",
"criterion": "patient status",
"requirement": {
"requirement_type": "status",
"expected_value": "inpatient"
}
}
}
},
{
"identified_line": {
"line": "* Grade II-IV peripheral neuropathy",
"criterions": [
{
"exact_snippets": "Grade II-IV peripheral neuropathy",
"criterion": "peripheral neuropathy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "Grade"
},
{
"operator": "<=",
"value": 4,
"unit": "Grade"
}
]
}
}
}
]
},
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"criterion": "peripheral neuropathy",
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"requirement_type": "severity",
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{
"operator": ">=",
"value": 2,
"unit": "Grade"
},
{
"operator": "<=",
"value": 4,
"unit": "Grade"
}
]
}
}
}
}
},
{
"identified_line": {
"line": "Patients will be excluded if they are or have had:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "* Known to be positive for HIV, hepatitis B or C",
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{
"exact_snippets": "Known to be positive for HIV",
"criterion": "HIV status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "positive for ... hepatitis B",
"criterion": "hepatitis B status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "positive for ... hepatitis C",
"criterion": "hepatitis C status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Known to be positive for HIV",
"criterion": "HIV status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "positive for ... hepatitis B",
"criterion": "hepatitis B status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "positive for ... hepatitis C",
"criterion": "hepatitis C status",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Clinically significant cardiac co-morbidities or pulmonary impairment",
"criterions": [
{
"exact_snippets": "Clinically significant cardiac co-morbidities",
"criterion": "cardiac co-morbidities",
"requirement": {
"requirement_type": "severity",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "pulmonary impairment",
"criterion": "pulmonary impairment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Concomitant therapy needs",
"criterions": [
{
"exact_snippets": "Concomitant therapy needs",
"criterion": "concomitant therapy",
"requirement": {
"requirement_type": "needs",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Treated with any investigational drugs within 30 days",
"criterions": [
{
"exact_snippets": "Treated with any investigational drugs within 30 days",
"criterion": "investigational drug treatment",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Tumors involve major artery or vein",
"criterions": [
{
"exact_snippets": "Tumors involve major artery or vein",
"criterion": "tumor involvement",
"requirement": {
"requirement_type": "location",
"expected_value": [
"major artery",
"major vein"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Prior or concurrent central nervous system (CNS) disease",
"criterions": [
{
"exact_snippets": "Prior or concurrent central nervous system (CNS) disease",
"criterion": "central nervous system (CNS) disease",
"requirement": {
"requirement_type": "temporal presence",
"expected_value": [
"prior",
"concurrent"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}