{
"info": {
"nct_id": "NCT00599924",
"official_title": "Phase I Study Of SU011248 In Combination With Oxaliplatin, Leucovorin, And 5-Fluorouracil In Patients With Advanced Solid Malignancies",
"inclusion_criteria": "* Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)\n* Eastern Cooperative Oncology Group (ECOG) 0 or 1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens\n* Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens\n* For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Advanced solid tumor malignancy (during expansion at the maximum tolerated dose, entry will be limited to patients wtih adenocarcinoma of the colon or rectum)",
"criterions": [
{
"exact_snippets": [
"Advanced solid tumor malignancy"
],
"criterion": "solid tumor malignancy",
"requirement_type": "stage",
"expected_value": "advanced"
},
{
"exact_snippets": [
"adenocarcinoma of the colon or rectum"
],
"criterion": "adenocarcinoma",
"requirement_type": "location",
"expected_value": [
"colon",
"rectum"
]
}
]
},
{
"line": "* Eastern Cooperative Oncology Group (ECOG) 0 or 1",
"criterions": [
{
"exact_snippets": [
"Eastern Cooperative Oncology Group (ECOG) 0 or 1"
],
"criterion": "Eastern Cooperative Oncology Group (ECOG) performance status",
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": [
"minimum age of 18 Years"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18
}
}
]
}
],
"exclusion_lines": [
{
"line": "* Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens",
"criterions": [
{
"exact_snippets": [
"Prior treatment with more than 6 cycles of traditional alkylating agent-based chemotherapy regimens"
],
"criterion": "traditional alkylating agent-based chemotherapy regimens",
"requirement_type": "prior treatment",
"expected_value": true
},
{
"exact_snippets": [
"more than 6 cycles"
],
"criterion": "cycles of traditional alkylating agent-based chemotherapy regimens",
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 6
}
]
}
}
]
},
{
"line": "* Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens",
"criterions": [
{
"exact_snippets": [
"Prior treatment with more than 2 cycles of carboplating-based chemotherapy regimens"
],
"criterion": "carboplating-based chemotherapy regimens",
"requirement_type": "prior treatment cycles",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 2
}
]
}
}
]
},
{
"line": "* For colorectal cancer patients in the expanded cohorts, prior treatment with more than 2 systemic chemotherapy regimens in the metastatic setting",
"criterions": [
{
"exact_snippets": [
"colorectal cancer patients"
],
"criterion": "colorectal cancer",
"requirement_type": "presence",
"expected_value": true
},
{
"exact_snippets": [
"prior treatment with more than 2 systemic chemotherapy regimens"
],
"criterion": "systemic chemotherapy regimens",
"requirement_type": "prior treatment count",
"expected_value": {
"operator": ">",
"value": 2
}
},
{
"exact_snippets": [
"in the metastatic setting"
],
"criterion": "metastatic setting",
"requirement_type": "treatment context",
"expected_value": true
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}