{
"info": {
"nct_id": "NCT02948101",
"official_title": "Pilot Study of the Pre-Conditioning Effects of Anti-Macrophage Therapy Using PD 0360324 in Recurrent Platinum-Resistant Epithelial Ovarian Cancer",
"inclusion_criteria": "* Written informed consent\n* Histology showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer\n* Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment\n* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined at least two lesions that can be accurately measured in at least one dimension (longest dimension to be recorded); each \"target\" lesion must be > 20 mm when measured by palpitation or >10 mm when measured by spiral computed tomography (CT), plain x-ray, magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT; PET/CT will be acceptable at baseline if PET/CT was previously performed and available; imaging must be performed within -28 to -7 days of starting therapy; the target lesion must be distinct from other tumor areas selected for pre-treatment biopsies\n* Subject must be willing to undergo protocol directed biopsies and blood draw for immune profiling\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy of >= 4 months in the attending physician's estimation\n* Estimated creatinine clearance > 40 mL/min by the Cockcroft-Gault formula\n* White blood cell (WBC) >= 3.0 x 10^3/ul\n* Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (> 1500 per mm^3)\n* Platelet count >= 100 x 10^9/L (> 100,000 per mm^3)\n* Hemoglobin >= 9.0 g/dL\n* Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >=60 years old and no menses for > 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry\n* Subject must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Signed informed consent for protocol PA13-0291\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Absence of a biopsiable lesion as determined by radiologist\n* Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer in the last 21 days\n* History of another primary malignancy except for:\n\n * Malignancy treated with curative intent and with no known active disease >=5 years before the first dose of study drug and of low potential risk for recurrence;\n * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or\n * Adequately treated carcinoma in situ without evidence of disease, e.g. cervical cancer in situ\n* Current or prior use of immunosuppressive medication within 21 days before the first dose of PD 0360324, with the exceptions of intranasal and inhaled corticosteroids and systemic corticosteroids at physiological doses (defined as not exceeding 10 mg/day of prednisone, or an equivalent dose of over corticosteroid)\n* Prior immunotherapy with immune checkpoint inhibitors\n* Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from previous anti-cancer therapy with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy)\n* Subjects with an active infection requiring antibiotics or at an increased risk of latent infection that may affect safe study participation\n* Subjects with existing periorbital edema\n* Subjects with aspartate aminotransferase (AST) or alanine transaminase (ALT) >= 2 x upper limit of normal (ULN)\n* Subjects with creatine kinase > ULN\n* Subjects with clinically significant active ischemic heart disease, cardiac muscle disease (including cardiomyopathy or congestive heart failure) or myodegenerative disorders that may affect safe study participation\n* Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days prior to study entry\n* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibodies (e.g., Enbrel which is the Fc portion of an antibody or Lucentis which is a Fab)\n* Pregnant or breastfeeding women or women of child-bearing potential who are not willing to use two highly effective methods of contraception (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence)\n* Uncontrolled intercurrent illness including, but not limited to, bowel obstruction, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), tuberculosis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent, or undergo study procedures\n* History of leptomeningeal carcinomatosis or brain metastasis",
"miscellaneous_criteria": ""
},
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},
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},
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]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequately treated carcinoma in situ",
"criterion": "carcinoma in situ",
"requirement": {
"requirement_type": "treatment status",
"expected_value": "adequately treated"
}
},
{
"exact_snippets": "without evidence of disease",
"criterion": "evidence of disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Current or prior use of immunosuppressive medication within 21 days before the first dose of PD 0360324, with the exceptions of intranasal and inhaled corticosteroids and systemic corticosteroids at physiological doses (defined as not exceeding 10 mg/day of prednisone, or an equivalent dose of over corticosteroid)",
"criterions": [
{
"exact_snippets": "Current or prior use of immunosuppressive medication within 21 days before the first dose of PD 0360324",
"criterion": "use of immunosuppressive medication",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 21 days before the first dose of PD 0360324"
}
},
{
"exact_snippets": "exceptions of intranasal and inhaled corticosteroids",
"criterion": "use of intranasal and inhaled corticosteroids",
"requirement": {
"requirement_type": "exception",
"expected_value": true
}
},
{
"exact_snippets": "exceptions of ... systemic corticosteroids at physiological doses",
"criterion": "use of systemic corticosteroids at physiological doses",
"requirement": {
"requirement_type": "exception",
"expected_value": true
}
},
{
"exact_snippets": "physiological doses (defined as not exceeding 10 mg/day of prednisone, or an equivalent dose of over corticosteroid)",
"criterion": "dose of systemic corticosteroids",
"requirement": {
"requirement_type": "maximum dose",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "mg/day of prednisone or equivalent"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Current or prior use of immunosuppressive medication within 21 days before the first dose of PD 0360324",
"criterion": "use of immunosuppressive medication",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 21 days before the first dose of PD 0360324"
}
},
{
"not_criteria": {
"exact_snippets": "exceptions of intranasal and inhaled corticosteroids",
"criterion": "use of intranasal and inhaled corticosteroids",
"requirement": {
"requirement_type": "exception",
"expected_value": true
}
}
},
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "exceptions of ... systemic corticosteroids at physiological doses",
"criterion": "use of systemic corticosteroids at physiological doses",
"requirement": {
"requirement_type": "exception",
"expected_value": true
}
},
{
"exact_snippets": "physiological doses (defined as not exceeding 10 mg/day of prednisone, or an equivalent dose of over corticosteroid)",
"criterion": "dose of systemic corticosteroids",
"requirement": {
"requirement_type": "maximum dose",
"expected_value": {
"operator": "<=",
"value": 10,
"unit": "mg/day of prednisone or equivalent"
}
}
}
]
}
}
]
}
}
]
}
},
{
"identified_line": {
"line": "* Prior immunotherapy with immune checkpoint inhibitors",
"criterions": [
{
"exact_snippets": "Prior immunotherapy with immune checkpoint inhibitors",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
},
{
"exact_snippets": "Prior immunotherapy with immune checkpoint inhibitors",
"criterion": "immune checkpoint inhibitors",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Prior immunotherapy with immune checkpoint inhibitors",
"criterion": "immunotherapy",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
},
{
"exact_snippets": "Prior immunotherapy with immune checkpoint inhibitors",
"criterion": "immune checkpoint inhibitors",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Subjects with an active infection requiring antibiotics or at an increased risk of latent infection that may affect safe study participation",
"criterions": [
{
"exact_snippets": "active infection requiring antibiotics",
"criterion": "active infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "antibiotics"
}
},
{
"exact_snippets": "increased risk of latent infection",
"criterion": "latent infection",
"requirement": {
"requirement_type": "risk",
"expected_value": "increased"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "active infection requiring antibiotics",
"criterion": "active infection",
"requirement": {
"requirement_type": "treatment",
"expected_value": "antibiotics"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "increased risk of latent infection",
"criterion": "latent infection",
"requirement": {
"requirement_type": "risk",
"expected_value": "increased"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Subjects with existing periorbital edema",
"criterions": [
{
"exact_snippets": "existing periorbital edema",
"criterion": "periorbital edema",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "existing periorbital edema",
"criterion": "periorbital edema",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Subjects with aspartate aminotransferase (AST) or alanine transaminase (ALT) >= 2 x upper limit of normal (ULN)",
"criterions": [
{
"exact_snippets": "aspartate aminotransferase (AST) ... >= 2 x upper limit of normal (ULN)",
"criterion": "aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "alanine transaminase (ALT) >= 2 x upper limit of normal (ULN)",
"criterion": "alanine transaminase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "x ULN"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "aspartate aminotransferase (AST) ... >= 2 x upper limit of normal (ULN)",
"criterion": "aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "x ULN"
}
}
},
{
"exact_snippets": "alanine transaminase (ALT) >= 2 x upper limit of normal (ULN)",
"criterion": "alanine transaminase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "x ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Subjects with creatine kinase > ULN",
"criterions": [
{
"exact_snippets": "creatine kinase > ULN",
"criterion": "creatine kinase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "ULN"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "creatine kinase > ULN",
"criterion": "creatine kinase",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "ULN"
}
}
}
}
},
{
"identified_line": {
"line": "* Subjects with clinically significant active ischemic heart disease, cardiac muscle disease (including cardiomyopathy or congestive heart failure) or myodegenerative disorders that may affect safe study participation",
"criterions": [
{
"exact_snippets": "clinically significant active ischemic heart disease",
"criterion": "ischemic heart disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clinically significant active ischemic heart disease",
"criterion": "ischemic heart disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
},
{
"exact_snippets": "clinically significant active ischemic heart disease",
"criterion": "ischemic heart disease",
"requirement": {
"requirement_type": "significance",
"expected_value": "clinically significant"
}
},
{
"exact_snippets": "cardiac muscle disease (including cardiomyopathy or congestive heart failure)",
"criterion": "cardiac muscle disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "myodegenerative disorders",
"criterion": "myodegenerative disorders",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "clinically significant active ischemic heart disease",
"criterion": "ischemic heart disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "clinically significant active ischemic heart disease",
"criterion": "ischemic heart disease",
"requirement": {
"requirement_type": "activity",
"expected_value": "active"
}
}
]
},
{
"exact_snippets": "clinically significant active ischemic heart disease",
"criterion": "ischemic heart disease",
"requirement": {
"requirement_type": "significance",
"expected_value": "clinically significant"
}
}
]
},
{
"exact_snippets": "cardiac muscle disease (including cardiomyopathy or congestive heart failure)",
"criterion": "cardiac muscle disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "myodegenerative disorders",
"criterion": "myodegenerative disorders",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days prior to study entry",
"criterions": [
{
"exact_snippets": "Receipt of live attenuated vaccination within 30 days prior to study entry",
"criterion": "live attenuated vaccination",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
},
{
"exact_snippets": "Receipt of live attenuated vaccination within 30 days prior to study entry",
"criterion": "live attenuated vaccination",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Receipt of live attenuated vaccination within 30 days prior to study entry",
"criterion": "live attenuated vaccination",
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"requirement_type": "receipt",
"expected_value": false
}
},
{
"exact_snippets": "Receipt of live attenuated vaccination within 30 days prior to study entry",
"criterion": "live attenuated vaccination",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 30,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibodies (e.g., Enbrel which is the Fc portion of an antibody or Lucentis which is a Fab)",
"criterions": [
{
"exact_snippets": "History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein)",
"criterion": "allergic or anaphylactic reaction to monoclonal antibody",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of allergic or anaphylactic reaction to ... molecules made of components of monoclonal antibodies (e.g., Enbrel which is the Fc portion of an antibody or Lucentis which is a Fab)",
"criterion": "allergic or anaphylactic reaction to molecules made of components of monoclonal antibodies",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein)",
"criterion": "allergic or anaphylactic reaction to monoclonal antibody",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of allergic or anaphylactic reaction to ... molecules made of components of monoclonal antibodies (e.g., Enbrel which is the Fc portion of an antibody or Lucentis which is a Fab)",
"criterion": "allergic or anaphylactic reaction to molecules made of components of monoclonal antibodies",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Uncontrolled intercurrent illness including, but not limited to, bowel obstruction, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), tuberculosis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent, or undergo study procedures",
"criterions": [
{
"exact_snippets": "Uncontrolled intercurrent illness ... bowel obstruction",
"criterion": "bowel obstruction",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... active peptic ulcer disease or gastritis",
"criterion": "peptic ulcer disease or gastritis",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... active bleeding diatheses",
"criterion": "bleeding diatheses",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... evidence of acute or chronic hepatitis B",
"criterion": "hepatitis B",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... evidence of acute or chronic ... hepatitis C",
"criterion": "hepatitis C",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... evidence of acute or chronic ... human immunodeficiency virus (HIV)",
"criterion": "human immunodeficiency virus (HIV)",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... tuberculosis",
"criterion": "tuberculosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on compliance",
"expected_value": "limit"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would ... compromise the ability of the subject to give written informed consent",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on consent ability",
"expected_value": "compromise"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would ... undergo study procedures",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on procedure ability",
"expected_value": "compromise"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Uncontrolled intercurrent illness ... bowel obstruction",
"criterion": "bowel obstruction",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... uncontrolled hypertension",
"criterion": "hypertension",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... active peptic ulcer disease or gastritis",
"criterion": "peptic ulcer disease or gastritis",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... active bleeding diatheses",
"criterion": "bleeding diatheses",
"requirement": {
"requirement_type": "activity status",
"expected_value": "active"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... evidence of acute or chronic hepatitis B",
"criterion": "hepatitis B",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... evidence of acute or chronic ... hepatitis C",
"criterion": "hepatitis C",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... evidence of acute or chronic ... human immunodeficiency virus (HIV)",
"criterion": "human immunodeficiency virus (HIV)",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... tuberculosis",
"criterion": "tuberculosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on compliance",
"expected_value": "limit"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would ... compromise the ability of the subject to give written informed consent",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on consent ability",
"expected_value": "compromise"
}
},
{
"exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would ... undergo study procedures",
"criterion": "psychiatric illness/social situations",
"requirement": {
"requirement_type": "impact on procedure ability",
"expected_value": "compromise"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* History of leptomeningeal carcinomatosis or brain metastasis",
"criterions": [
{
"exact_snippets": "History of leptomeningeal carcinomatosis",
"criterion": "leptomeningeal carcinomatosis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... brain metastasis",
"criterion": "brain metastasis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of leptomeningeal carcinomatosis",
"criterion": "leptomeningeal carcinomatosis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... brain metastasis",
"criterion": "brain metastasis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Histology showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterions": [
{
"exact_snippets": "Histology showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "histology",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "types",
"expected_value": [
"epithelial ovarian",
"peritoneal",
"fallopian tube"
]
}
},
{
"exact_snippets": "recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "grade",
"expected_value": "high"
}
},
{
"exact_snippets": "recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histology showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "histology",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "types",
"expected_value": [
"epithelial ovarian"
]
}
},
{
"exact_snippets": "recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "types",
"expected_value": [
"peritoneal"
]
}
},
{
"exact_snippets": "recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "types",
"expected_value": [
"fallopian tube"
]
}
}
]
}
]
},
{
"exact_snippets": "recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "grade",
"expected_value": "high"
}
},
{
"exact_snippets": "recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer",
"criterion": "cancer type",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment",
"criterions": [
{
"exact_snippets": "Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen",
"criterion": "platinum resistance or refractoriness",
"requirement": {
"requirement_type": "definition",
"expected_value": "progression of disease on a platinum-containing regimen"
}
},
{
"exact_snippets": "recurrence of disease within 180 days of previous platinum treatment",
"criterion": "recurrence of disease",
"requirement": {
"requirement_type": "time since previous treatment",
"expected_value": {
"operator": "<=",
"value": 180,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined at least two lesions that can be accurately measured in at least one dimension (longest dimension to be recorded); each \"target\" lesion must be > 20 mm when measured by palpitation or >10 mm when measured by spiral computed tomography (CT), plain x-ray, magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT; PET/CT will be acceptable at baseline if PET/CT was previously performed and available; imaging must be performed within -28 to -7 days of starting therapy; the target lesion must be distinct from other tumor areas selected for pre-treatment biopsies",
"criterions": [
{
"exact_snippets": "measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "definition",
"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) 1.1"
}
},
{
"exact_snippets": "measurable disease is defined at least two lesions that can be accurately measured in at least one dimension",
"criterion": "lesions",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "lesions"
}
}
},
{
"exact_snippets": "measurable disease is defined at least two lesions that can be accurately measured in at least one dimension",
"criterion": "lesions",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
},
{
"exact_snippets": "each \"target\" lesion must be > 20 mm when measured by palpitation",
"criterion": "target lesion size by palpitation",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 20,
"unit": "mm"
}
}
},
{
"exact_snippets": ">10 mm when measured by spiral computed tomography (CT), plain x-ray, magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT",
"criterion": "target lesion size by imaging",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 10,
"unit": "mm"
}
}
},
{
"exact_snippets": "PET/CT will be acceptable at baseline if PET/CT was previously performed and available",
"criterion": "PET/CT availability",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "imaging must be performed within -28 to -7 days of starting therapy",
"criterion": "imaging timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": -28,
"unit": "days"
},
{
"operator": "<=",
"value": -7,
"unit": "days"
}
]
}
}
},
{
"exact_snippets": "the target lesion must be distinct from other tumor areas selected for pre-treatment biopsies",
"criterion": "target lesion distinctness",
"requirement": {
"requirement_type": "distinctness",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Subject must be willing to undergo protocol directed biopsies and blood draw for immune profiling",
"criterions": [
{
"exact_snippets": "Subject must be willing to undergo protocol directed biopsies",
"criterion": "willingness to undergo biopsies",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "Subject must be willing to undergo ... blood draw for immune profiling",
"criterion": "willingness to undergo blood draw",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer in the last 21 days",
"criterions": [
{
"exact_snippets": "Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer",
"criterion": "treatment type",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"chemotherapy",
"hormonal",
"biologic"
]
}
},
{
"exact_snippets": "in the last 21 days",
"criterion": "treatment timing",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer",
"criterion": "treatment type",
"requirement": {
"requirement_type": "presence",
"expected_value": "chemotherapy"
}
},
{
"exact_snippets": "Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer",
"criterion": "treatment type",
"requirement": {
"requirement_type": "presence",
"expected_value": "hormonal"
}
},
{
"exact_snippets": "Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer",
"criterion": "treatment type",
"requirement": {
"requirement_type": "presence",
"expected_value": "biologic"
}
}
]
},
{
"exact_snippets": "in the last 21 days",
"criterion": "treatment timing",
"requirement": {
"requirement_type": "recency",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Any unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from previous anti-cancer therapy with the exception of alopecia; subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripheral neuropathy)",
"criterions": [
{
"exact_snippets": "unresolved toxicity (> Common Terminology Criteria for Adverse Events [CTCAE] grade 1) from previous anti-cancer therapy",
"criterion": "unresolved toxicity from previous anti-cancer therapy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "CTCAE grade"
}
}
},
{
"exact_snippets": "alopecia",
"criterion": "alopecia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product",
"criterion": "irreversible toxicity",
"requirement": {
"requirement_type": "exacerbation by investigational product",
"expected_value": false
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Pregnant or breastfeeding women or women of child-bearing potential who are not willing to use two highly effective methods of contraception (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence)",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breastfeeding women",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "women of child-bearing potential",
"criterion": "women of child-bearing potential",
"requirement": {
"requirement_type": "willingness to use contraception",
"expected_value": true
}
},
{
"exact_snippets": "willing to use two highly effective methods of contraception",
"criterion": "contraception methods",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "methods"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "women of child-bearing potential",
"criterion": "women of child-bearing potential",
"requirement": {
"requirement_type": "willingness to use contraception",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "breastfeeding women",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "women of child-bearing potential",
"criterion": "women of child-bearing potential",
"requirement": {
"requirement_type": "willingness to use contraception",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "women of child-bearing potential",
"criterion": "women of child-bearing potential",
"requirement": {
"requirement_type": "willingness to use contraception",
"expected_value": true
}
},
{
"exact_snippets": "willing to use two highly effective methods of contraception",
"criterion": "contraception methods",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "methods"
}
}
}
]
}
]
}
}
],
"failed_miscellaneous": []
}