{
"info": {
"nct_id": "NCT04550494",
"official_title": "A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response",
"inclusion_criteria": "* Adult patients with solid tumors and documented germline or somatic aberrations in genes involved in DNA damage response (DDR) and whose disease has progressed following at least one standard therapy or who have no acceptable standard treatment options. Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable for determination of eligibility\n* Patients with the following germline or somatic genetic aberrations will be eligible based on compelling preclinical and/or clinical data suggesting that these deleterious mutations confer sensitivity to PARP inhibitors; no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene will be enrolled\n\n * Deleterious BRCA1 or BRCA2 mutations\n * Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN\n * A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L\n* Age >= 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =< 2\n* Life expectancy of greater than 3 months\n* Leukocytes >= 3,000/mcL\n* Absolute neutrophil count >= 1,500/mcL\n* Platelets >= 100,000/mcL\n* Hemoglobin >= 10 g/dL\n* Total bilirubin =< 1.5 x institutional upper limit of normal (=< 3 x upper limit of normal in the presence of documented Gilbert's syndrome or liver metastases at baseline)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional upper limit of normal\n* Creatinine =< 1.5 x institutional upper limit of normal OR Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73m^2\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with CT scan, MRI, or calipers by clinical exam\n* Patients must have a tumor site amenable to biopsy. If avoidable, the lesion for biopsy should not be selected as a target lesion for RECIST measurements\n* The effects of talazoparib on the developing human fetus are unknown. For this reason and because PARP inhibitors are known to be teratogenic, women of child-bearing potential must agree to use a highly effective method of contraception for the duration of study participation and for at least 7 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male patients with female partners of reproductive potential and pregnant partners who are treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for at least 4 months after completion of talazoparib administration\n* Patients must be able to swallow whole tablets or capsules. Nasogastric or gastric-tube (G-tube) administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients must have recurrent, locally advanced or metastatic disease\n* Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention, except for those patients without SOC or for whom talazoparib is SOC\n* PATIENTS WITH OVARIAN CANCER:\n* All patients with ovarian cancer should have one prior platinum-based therapy\n* Patients with ovarian cancer with platinum-sensitive disease are eligible. Patients with platinum-refractory disease are not eligible\n* Patients with gBRCAm ovarian cancer must also have progressed on a PARP inhibitor. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH PANCREATIC CANCER:\n* All patients with pancreatic cancer should have received prior platinum-containing therapy in the metastatic setting\n* PATIENTS WITH BREAST CANCER:\n* Patients with HER2+ breast cancer should have had 2 prior systemic lines of therapy in the metastatic setting, including anti-HER2 therapy\n* Patients with breast cancer who are eligible for a PARP inhibitor by Food and Drug Association (FDA) approvals must have had prior PARP inhibitor as per FDA indication. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH GASTRIC CANCER:\n* Patients with HER2+ gastric cancer should have had received anti-HER2 therapy in the metastatic setting\n* PATIENTS WITH PROSTATE CANCER:\n* Patients with prostate cancer who are eligible for a PARP inhibitor by FDA approvals must have had prior PARP inhibitor for eligibility. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* All patients with prostate cancer can continue to receive treatment with gonadotropin-releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on prior therapy\n* Patients with castration resistant prostate cancer must have castrate levels of testosterone (< 50 ng/dL [1.74 nmol/L])\n* Patients with metastatic hormone receptor (HR) prostate cancer and mutations in either BRCA1, BRCA2, or ATM should continue to receive anti-androgen receptor (anti-AR) therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter (6 weeks for nitrosoureas or mitomycin C). Patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be >= 1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events\n* Patients who have had prior treatment with talazoparib are ineligible\n* Patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment) except for monoclonal antibody therapies that have been proven to be safe when combined with PARP inhibitor (PARPi) treatment (such as anti-PD-1/PD-L1 and anti-HER2), which must be completed >= 4 weeks prior to enrollment\n* Patients who are receiving any other investigational agents\n* Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for >= 1 month without requiring steroid and anti-seizure medication are eligible to participate\n* Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib will be determined following review by the principal investigator\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because the effects of the study drugs on the developing fetus are unknown\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded. Low-dose warfarin (=< 1 mg/day) is permitted\n* Women who are currently lactating\n* History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Adult patients with solid tumors and documented germline or somatic aberrations in genes involved in DNA damage response (DDR) and whose disease has progressed following at least one standard therapy or who have no acceptable standard treatment options. Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable for determination of eligibility",
"criterions": [
{
"exact_snippets": "Adult patients",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": ">= 18"
}
},
{
"exact_snippets": "solid tumors",
"criterion": "tumor type",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "documented germline or somatic aberrations in genes involved in DNA damage response (DDR)",
"criterion": "DDR gene aberrations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "disease has progressed following at least one standard therapy",
"criterion": "disease progression after therapy",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
},
{
"exact_snippets": "no acceptable standard treatment options",
"criterion": "standard treatment options",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
},
{
"exact_snippets": "Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable",
"criterion": "molecular testing location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"NCI-MATCH CLIA laboratory",
"Myriad Genetics",
"GeneDx",
"Invitae",
"Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha)"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adult patients",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": ">= 18"
}
},
{
"exact_snippets": "solid tumors",
"criterion": "tumor type",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "documented germline or somatic aberrations in genes involved in DNA damage response (DDR)",
"criterion": "DDR gene aberrations",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "disease has progressed following at least one standard therapy",
"criterion": "disease progression after therapy",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
},
{
"exact_snippets": "no acceptable standard treatment options",
"criterion": "standard treatment options",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
}
]
}
]
},
{
"exact_snippets": "Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable",
"criterion": "molecular testing location",
"requirement": {
"requirement_type": "location",
"expected_value": [
"NCI-MATCH CLIA laboratory",
"Myriad Genetics",
"GeneDx",
"Invitae",
"Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha)"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients with the following germline or somatic genetic aberrations will be eligible based on compelling preclinical and/or clinical data suggesting that these deleterious mutations confer sensitivity to PARP inhibitors; no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene will be enrolled",
"criterions": [
{
"exact_snippets": "germline or somatic genetic aberrations",
"criterion": "genetic aberrations",
"requirement": {
"requirement_type": "type",
"expected_value": [
"germline",
"somatic"
]
}
},
{
"exact_snippets": "deleterious mutations",
"criterion": "mutations",
"requirement": {
"requirement_type": "severity",
"expected_value": "deleterious"
}
},
{
"exact_snippets": "sensitivity to PARP inhibitors",
"criterion": "sensitivity to PARP inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene",
"criterion": "patients with an eligibility mutation in any one gene",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "patients"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "germline or somatic genetic aberrations",
"criterion": "genetic aberrations",
"requirement": {
"requirement_type": "type",
"expected_value": [
"germline",
"somatic"
]
}
},
{
"exact_snippets": "deleterious mutations",
"criterion": "mutations",
"requirement": {
"requirement_type": "severity",
"expected_value": "deleterious"
}
}
]
},
{
"exact_snippets": "sensitivity to PARP inhibitors",
"criterion": "sensitivity to PARP inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene",
"criterion": "patients with an eligibility mutation in any one gene",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "patients"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Deleterious BRCA1 or BRCA2 mutations",
"criterions": [
{
"exact_snippets": "Deleterious BRCA1 or BRCA2 mutations",
"criterion": "BRCA1 or BRCA2 mutations",
"requirement": {
"requirement_type": "deleterious",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Deleterious BRCA1 or BRCA2 mutations",
"criterion": "BRCA1 or BRCA2 mutations",
"requirement": {
"requirement_type": "deleterious",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN",
"criterions": [
{
"exact_snippets": "Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN",
"criterion": "loss of function mutations in Fanconi anemia genes",
"requirement": {
"requirement_type": "genes",
"expected_value": [
"FANCA",
"FANCB",
"FANCC",
"FANCD2",
"FANCE",
"FANCF",
"FANCG",
"FANCI",
"FANCJ",
"FANCL",
"FANCM",
"FANCN"
]
}
},
{
"exact_snippets": "Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN",
"criterion": "loss of function mutations in Fanconi anemia genes",
"requirement": {
"requirement_type": "mutation types",
"expected_value": [
"loss of function",
"frameshift",
"nonsense"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN",
"criterion": "loss of function mutations in Fanconi anemia genes",
"requirement": {
"requirement_type": "genes",
"expected_value": [
"FANCA",
"FANCB",
"FANCC",
"FANCD2",
"FANCE",
"FANCF",
"FANCG",
"FANCI",
"FANCJ",
"FANCL",
"FANCM",
"FANCN"
]
}
},
{
"exact_snippets": "Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN",
"criterion": "loss of function mutations in Fanconi anemia genes",
"requirement": {
"requirement_type": "mutation types",
"expected_value": [
"loss of function",
"frameshift",
"nonsense"
]
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L",
"criterions": [
{
"exact_snippets": "A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L",
"criterion": "DDR gene mutation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L",
"criterion": "DDR gene mutation",
"requirement": {
"requirement_type": "type",
"expected_value": [
"functional mutation",
"novel loss of function frameshift",
"nonsense mutations"
]
}
},
{
"exact_snippets": "A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L",
"criterion": "DDR gene mutation",
"requirement": {
"requirement_type": "genes",
"expected_value": [
"ARID1A",
"ATM",
"ATR",
"BACH1 (BRIP1)",
"BAP1",
"BARD1",
"CDK12",
"CHK1",
"CHK2",
"IDH1",
"IDH2",
"MRE11A",
"NBN",
"PALB2",
"RAD50",
"RAD51",
"RAD51B",
"RAD51C",
"RAD51D",
"RAD54L"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L",
"criterion": "DDR gene mutation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L",
"criterion": "DDR gene mutation",
"requirement": {
"requirement_type": "type",
"expected_value": [
"functional mutation",
"novel loss of function frameshift",
"nonsense mutations"
]
}
}
]
},
{
"exact_snippets": "A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L",
"criterion": "DDR gene mutation",
"requirement": {
"requirement_type": "genes",
"expected_value": [
"ARID1A",
"ATM",
"ATR",
"BACH1 (BRIP1)",
"BAP1",
"BARD1",
"CDK12",
"CHK1",
"CHK2",
"IDH1",
"IDH2",
"MRE11A",
"NBN",
"PALB2",
"RAD50",
"RAD51",
"RAD51B",
"RAD51C",
"RAD51D",
"RAD54L"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Age >= 18 years of age",
"criterions": [
{
"exact_snippets": "Age >= 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age >= 18 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status =< 2",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status =< 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "performance status",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status =< 2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "performance status",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy of greater than 3 months",
"criterions": [
{
"exact_snippets": "Life expectancy of greater than 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy of greater than 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Leukocytes >= 3,000/mcL",
"criterions": [
{
"exact_snippets": "Leukocytes >= 3,000/mcL",
"criterion": "leukocytes",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3000,
"unit": "mcL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Leukocytes >= 3,000/mcL",
"criterion": "leukocytes",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 3000,
"unit": "mcL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Absolute neutrophil count >= 1,500/mcL",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count >= 1,500/mcL",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mcL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute neutrophil count >= 1,500/mcL",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mcL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelets >= 100,000/mcL",
"criterions": [
{
"exact_snippets": "Platelets >= 100,000/mcL",
"criterion": "platelets",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mcL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Platelets >= 100,000/mcL",
"criterion": "platelets",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mcL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin >= 10 g/dL",
"criterions": [
{
"exact_snippets": "Hemoglobin >= 10 g/dL",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "g/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hemoglobin >= 10 g/dL",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "g/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Total bilirubin =< 1.5 x institutional upper limit of normal (=< 3 x upper limit of normal in the presence of documented Gilbert's syndrome or liver metastases at baseline)",
"criterions": [
{
"exact_snippets": "Total bilirubin =< 1.5 x institutional upper limit of normal",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional upper limit of normal"
}
}
},
{
"exact_snippets": "Gilbert's syndrome",
"criterion": "Gilbert's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "liver metastases at baseline",
"criterion": "liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"or_criteria": [
{
"exact_snippets": "Gilbert's syndrome",
"criterion": "Gilbert's syndrome",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "liver metastases at baseline",
"criterion": "liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"then_criteria": {
"exact_snippets": "Total bilirubin =< 1.5 x institutional upper limit of normal",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x upper limit of normal"
}
}
},
"else_criteria": {
"exact_snippets": "Total bilirubin =< 1.5 x institutional upper limit of normal",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional upper limit of normal"
}
}
}
}
},
{
"identified_line": {
"line": "* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional upper limit of normal",
"criterions": [
{
"exact_snippets": "Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ... =< 3 x institutional upper limit of normal",
"criterion": "aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x institutional upper limit of normal"
}
}
},
{
"exact_snippets": "alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional upper limit of normal",
"criterion": "alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x institutional upper limit of normal"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ... =< 3 x institutional upper limit of normal",
"criterion": "aspartate aminotransferase (AST)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x institutional upper limit of normal"
}
}
},
{
"exact_snippets": "alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional upper limit of normal",
"criterion": "alanine aminotransferase (ALT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x institutional upper limit of normal"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine =< 1.5 x institutional upper limit of normal OR Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73m^2",
"criterions": [
{
"exact_snippets": "Creatinine =< 1.5 x institutional upper limit of normal",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional upper limit of normal"
}
}
},
{
"exact_snippets": "Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 ... no lower than 30 mL/min/1.73m^2",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "mL/min/1.73m^2"
}
}
},
{
"exact_snippets": "Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 ... no lower than 30 mL/min/1.73m^2",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "mL/min/1.73m^2"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Creatinine =< 1.5 x institutional upper limit of normal",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x institutional upper limit of normal"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 ... no lower than 30 mL/min/1.73m^2",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "mL/min/1.73m^2"
}
}
},
{
"condition": {
"exact_snippets": "Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 ... no lower than 30 mL/min/1.73m^2",
"criterion": "data supporting safe use at lower kidney function values",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 ... no lower than 30 mL/min/1.73m^2",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "mL/min/1.73m^2"
}
}
},
"else_criteria": null
}
]
},
{
"and_criteria": [
{
"condition": {
"exact_snippets": "Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 ... no lower than 30 mL/min/1.73m^2",
"criterion": "data supporting safe use at lower kidney function values",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Creatinine clearance (CrCl) >= 60 mL/min/1.73m^2 ... no lower than 30 mL/min/1.73m^2",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": ">=",
"value": 30,
"unit": "mL/min/1.73m^2"
}
}
},
"else_criteria": null
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with CT scan, MRI, or calipers by clinical exam",
"criterions": [
{
"exact_snippets": "measurable disease, defined as at least one lesion that can be accurately measured",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least one lesion that can be accurately measured in at least one dimension",
"criterion": "lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
},
{
"exact_snippets": "longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions",
"criterion": "lesion measurement",
"requirement": {
"requirement_type": "method",
"expected_value": [
"longest diameter for non-nodal lesions",
"short axis for nodal lesions"
]
}
},
{
"exact_snippets": "as >= 20 mm (>= 2 cm) by chest x-ray",
"criterion": "lesion size by chest x-ray",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
},
{
"exact_snippets": "as >= 10 mm (>= 1 cm) with CT scan, MRI, or calipers by clinical exam",
"criterion": "lesion size by CT scan, MRI, or calipers",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "measurable disease, defined as at least one lesion that can be accurately measured",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least one lesion that can be accurately measured in at least one dimension",
"criterion": "lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
},
{
"exact_snippets": "longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions",
"criterion": "lesion measurement",
"requirement": {
"requirement_type": "method",
"expected_value": [
"longest diameter for non-nodal lesions",
"short axis for nodal lesions"
]
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "as >= 20 mm (>= 2 cm) by chest x-ray",
"criterion": "lesion size by chest x-ray",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
},
{
"exact_snippets": "as >= 10 mm (>= 1 cm) with CT scan, MRI, or calipers by clinical exam",
"criterion": "lesion size by CT scan, MRI, or calipers",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients must have a tumor site amenable to biopsy. If avoidable, the lesion for biopsy should not be selected as a target lesion for RECIST measurements",
"criterions": [
{
"exact_snippets": "tumor site amenable to biopsy",
"criterion": "tumor site",
"requirement": {
"requirement_type": "amenability to biopsy",
"expected_value": true
}
},
{
"exact_snippets": "lesion for biopsy should not be selected as a target lesion for RECIST measurements",
"criterion": "lesion for biopsy",
"requirement": {
"requirement_type": "selection as target lesion for RECIST measurements",
"expected_value": false
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "tumor site amenable to biopsy",
"criterion": "tumor site",
"requirement": {
"requirement_type": "amenability to biopsy",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "lesion for biopsy should not be selected as a target lesion for RECIST measurements",
"criterion": "lesion for biopsy",
"requirement": {
"requirement_type": "selection as target lesion for RECIST measurements",
"expected_value": false
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* The effects of talazoparib on the developing human fetus are unknown. For this reason and because PARP inhibitors are known to be teratogenic, women of child-bearing potential must agree to use a highly effective method of contraception for the duration of study participation and for at least 7 months after completing study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male patients with female partners of reproductive potential and pregnant partners who are treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for at least 4 months after completion of talazoparib administration",
"criterions": [
{
"exact_snippets": "women of child-bearing potential must agree to use a highly effective method of contraception",
"criterion": "contraception use for women of child-bearing potential",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "for the duration of study participation and for at least 7 months after completing study treatment",
"criterion": "contraception duration for women of child-bearing potential",
"requirement": {
"requirement_type": "duration",
"expected_value": "for the duration of study participation and for at least 7 months after completing study treatment"
}
},
{
"exact_snippets": "Male patients with female partners of reproductive potential and pregnant partners ... must also agree to use adequate contraception",
"criterion": "contraception use for male patients with female partners of reproductive potential",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "for the duration of study participation and for at least 4 months after completion of talazoparib administration",
"criterion": "contraception duration for male patients with female partners of reproductive potential",
"requirement": {
"requirement_type": "duration",
"expected_value": "for the duration of study participation and for at least 4 months after completion of talazoparib administration"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "women of child-bearing potential must agree to use a highly effective method of contraception",
"criterion": "contraception use for women of child-bearing potential",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "for the duration of study participation and for at least 7 months after completing study treatment",
"criterion": "contraception duration for women of child-bearing potential",
"requirement": {
"requirement_type": "duration",
"expected_value": "for the duration of study participation and for at least 7 months after completing study treatment"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Male patients with female partners of reproductive potential and pregnant partners ... must also agree to use adequate contraception",
"criterion": "contraception use for male patients with female partners of reproductive potential",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "for the duration of study participation and for at least 4 months after completion of talazoparib administration",
"criterion": "contraception duration for male patients with female partners of reproductive potential",
"requirement": {
"requirement_type": "duration",
"expected_value": "for the duration of study participation and for at least 4 months after completion of talazoparib administration"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients must be able to swallow whole tablets or capsules. Nasogastric or gastric-tube (G-tube) administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed",
"criterions": [
{
"exact_snippets": "Patients must be able to swallow whole tablets or capsules.",
"criterion": "ability to swallow tablets or capsules",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Nasogastric or gastric-tube (G-tube) administration is not allowed.",
"criterion": "nasogastric or gastric-tube administration",
"requirement": {
"requirement_type": "allowance",
"expected_value": false
}
},
{
"exact_snippets": "Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed",
"criterion": "gastrointestinal disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients must be able to swallow whole tablets or capsules.",
"criterion": "ability to swallow tablets or capsules",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Nasogastric or gastric-tube (G-tube) administration is not allowed.",
"criterion": "nasogastric or gastric-tube administration",
"requirement": {
"requirement_type": "allowance",
"expected_value": false
}
}
]
},
{
"exact_snippets": "Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed",
"criterion": "gastrointestinal disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Ability to understand and the willingness to sign a written informed consent document",
"criterions": [
{
"exact_snippets": "Ability to understand",
"criterion": "ability to understand",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to sign informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Ability to understand",
"criterion": "ability to understand",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to sign informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must have recurrent, locally advanced or metastatic disease",
"criterions": [
{
"exact_snippets": "recurrent",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "locally advanced",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
},
{
"exact_snippets": "metastatic",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "recurrent",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "locally advanced",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "recurrent",
"criterion": "disease recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "metastatic",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "metastatic"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention, except for those patients without SOC or for whom talazoparib is SOC",
"criterions": [
{
"exact_snippets": "Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention",
"criterion": "progression on standard-of-care intervention",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
},
{
"exact_snippets": "except for those patients without SOC",
"criterion": "availability of standard-of-care",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
},
{
"exact_snippets": "for whom talazoparib is SOC",
"criterion": "talazoparib as standard-of-care",
"requirement": {
"requirement_type": "standard-of-care",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention",
"criterion": "progression on standard-of-care intervention",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
},
{
"exact_snippets": "except for those patients without SOC",
"criterion": "availability of standard-of-care",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "except for those patients without SOC",
"criterion": "availability of standard-of-care",
"requirement": {
"requirement_type": "availability",
"expected_value": false
}
},
{
"exact_snippets": "for whom talazoparib is SOC",
"criterion": "talazoparib as standard-of-care",
"requirement": {
"requirement_type": "standard-of-care",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* PATIENTS WITH OVARIAN CANCER:",
"criterions": [
{
"exact_snippets": "PATIENTS WITH OVARIAN CANCER",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PATIENTS WITH OVARIAN CANCER",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* All patients with ovarian cancer should have one prior platinum-based therapy",
"criterions": [
{
"exact_snippets": "patients with ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "one prior platinum-based therapy",
"criterion": "prior platinum-based therapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "patients with ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "one prior platinum-based therapy",
"criterion": "prior platinum-based therapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with ovarian cancer with platinum-sensitive disease are eligible. Patients with platinum-refractory disease are not eligible",
"criterions": [
{
"exact_snippets": "ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "platinum-sensitive disease",
"criterion": "platinum-sensitive disease",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
},
{
"exact_snippets": "platinum-refractory disease",
"criterion": "platinum-refractory disease",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "ovarian cancer",
"criterion": "ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "platinum-sensitive disease",
"criterion": "platinum-sensitive disease",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
]
},
{
"not_criteria": {
"exact_snippets": "platinum-refractory disease",
"criterion": "platinum-refractory disease",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with gBRCAm ovarian cancer must also have progressed on a PARP inhibitor. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterions": [
{
"exact_snippets": "gBRCAm ovarian cancer",
"criterion": "gBRCAm ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "progressed on a PARP inhibitor",
"criterion": "progression on a PARP inhibitor",
"requirement": {
"requirement_type": "status",
"expected_value": "progressed"
}
},
{
"exact_snippets": "The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterion": "documentation of time and treatment between prior PARP inhibitor and protocol initiation",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "gBRCAm ovarian cancer",
"criterion": "gBRCAm ovarian cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "progressed on a PARP inhibitor",
"criterion": "progression on a PARP inhibitor",
"requirement": {
"requirement_type": "status",
"expected_value": "progressed"
}
},
{
"exact_snippets": "The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterion": "documentation of time and treatment between prior PARP inhibitor and protocol initiation",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* PATIENTS WITH PANCREATIC CANCER:",
"criterions": [
{
"exact_snippets": "PATIENTS WITH PANCREATIC CANCER",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PATIENTS WITH PANCREATIC CANCER",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* All patients with pancreatic cancer should have received prior platinum-containing therapy in the metastatic setting",
"criterions": [
{
"exact_snippets": "patients with pancreatic cancer",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "received prior platinum-containing therapy",
"criterion": "prior platinum-containing therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "in the metastatic setting",
"criterion": "metastatic setting",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "patients with pancreatic cancer",
"criterion": "pancreatic cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "received prior platinum-containing therapy",
"criterion": "prior platinum-containing therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "in the metastatic setting",
"criterion": "metastatic setting",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* PATIENTS WITH BREAST CANCER:",
"criterions": [
{
"exact_snippets": "PATIENTS WITH BREAST CANCER",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PATIENTS WITH BREAST CANCER",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with HER2+ breast cancer should have had 2 prior systemic lines of therapy in the metastatic setting, including anti-HER2 therapy",
"criterions": [
{
"exact_snippets": "HER2+ breast cancer",
"criterion": "HER2+ breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "2 prior systemic lines of therapy in the metastatic setting",
"criterion": "prior systemic lines of therapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "lines"
}
}
},
{
"exact_snippets": "including anti-HER2 therapy",
"criterion": "anti-HER2 therapy",
"requirement": {
"requirement_type": "inclusion",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "HER2+ breast cancer",
"criterion": "HER2+ breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "2 prior systemic lines of therapy in the metastatic setting",
"criterion": "prior systemic lines of therapy",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "lines"
}
}
},
{
"exact_snippets": "including anti-HER2 therapy",
"criterion": "anti-HER2 therapy",
"requirement": {
"requirement_type": "inclusion",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with breast cancer who are eligible for a PARP inhibitor by Food and Drug Association (FDA) approvals must have had prior PARP inhibitor as per FDA indication. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterions": [
{
"exact_snippets": "Patients with breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "eligible for a PARP inhibitor by Food and Drug Association (FDA) approvals",
"criterion": "PARP inhibitor eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "FDA approvals"
}
},
{
"exact_snippets": "must have had prior PARP inhibitor as per FDA indication",
"criterion": "prior PARP inhibitor",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": "FDA indication"
}
},
{
"exact_snippets": "The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterion": "documentation of time and treatment",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients with breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "eligible for a PARP inhibitor by Food and Drug Association (FDA) approvals",
"criterion": "PARP inhibitor eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "FDA approvals"
}
}
]
},
{
"exact_snippets": "must have had prior PARP inhibitor as per FDA indication",
"criterion": "prior PARP inhibitor",
"requirement": {
"requirement_type": "prior treatment",
"expected_value": "FDA indication"
}
},
{
"exact_snippets": "The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterion": "documentation of time and treatment",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* PATIENTS WITH GASTRIC CANCER:",
"criterions": [
{
"exact_snippets": "PATIENTS WITH GASTRIC CANCER",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PATIENTS WITH GASTRIC CANCER",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with HER2+ gastric cancer should have had received anti-HER2 therapy in the metastatic setting",
"criterions": [
{
"exact_snippets": "HER2+ gastric cancer",
"criterion": "HER2+ gastric cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "received anti-HER2 therapy in the metastatic setting",
"criterion": "anti-HER2 therapy in the metastatic setting",
"requirement": {
"requirement_type": "treatment history",
"expected_value": "received"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "HER2+ gastric cancer",
"criterion": "HER2+ gastric cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "received anti-HER2 therapy in the metastatic setting",
"criterion": "anti-HER2 therapy in the metastatic setting",
"requirement": {
"requirement_type": "treatment history",
"expected_value": "received"
}
}
]
}
},
{
"identified_line": {
"line": "* PATIENTS WITH PROSTATE CANCER:",
"criterions": [
{
"exact_snippets": "PATIENTS WITH PROSTATE CANCER",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "PATIENTS WITH PROSTATE CANCER",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with prostate cancer who are eligible for a PARP inhibitor by FDA approvals must have had prior PARP inhibitor for eligibility. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterions": [
{
"exact_snippets": "Patients with prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "eligible for a PARP inhibitor by FDA approvals",
"criterion": "PARP inhibitor eligibility by FDA",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
},
{
"exact_snippets": "must have had prior PARP inhibitor",
"criterion": "prior PARP inhibitor treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterion": "documentation of time and treatment between prior PARP inhibitor and protocol initiation",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients with prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "eligible for a PARP inhibitor by FDA approvals",
"criterion": "PARP inhibitor eligibility by FDA",
"requirement": {
"requirement_type": "eligibility",
"expected_value": true
}
}
]
},
{
"exact_snippets": "must have had prior PARP inhibitor",
"criterion": "prior PARP inhibitor treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "The time and treatment between the prior PARP inhibitor and protocol initiation must be documented",
"criterion": "documentation of time and treatment between prior PARP inhibitor and protocol initiation",
"requirement": {
"requirement_type": "documentation",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* All patients with prostate cancer can continue to receive treatment with gonadotropin-releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on prior therapy",
"criterions": [
{
"exact_snippets": "prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "evidence of disease progression on prior therapy",
"criterion": "disease progression on prior therapy",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "evidence of disease progression on prior therapy",
"criterion": "disease progression on prior therapy",
"requirement": {
"requirement_type": "evidence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with castration resistant prostate cancer must have castrate levels of testosterone (< 50 ng/dL [1.74 nmol/L])",
"criterions": [
{
"exact_snippets": "Patients with castration resistant prostate cancer",
"criterion": "castration resistant prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must have castrate levels of testosterone (< 50 ng/dL [1.74 nmol/L])",
"criterion": "testosterone levels",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "ng/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients with castration resistant prostate cancer",
"criterion": "castration resistant prostate cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "must have castrate levels of testosterone (< 50 ng/dL [1.74 nmol/L])",
"criterion": "testosterone levels",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "ng/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with metastatic hormone receptor (HR) prostate cancer and mutations in either BRCA1, BRCA2, or ATM should continue to receive anti-androgen receptor (anti-AR) therapy",
"criterions": [
{
"exact_snippets": "metastatic hormone receptor (HR) prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "metastasis",
"expected_value": true
}
},
{
"exact_snippets": "metastatic hormone receptor (HR) prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "hormone receptor status",
"expected_value": "positive"
}
},
{
"exact_snippets": "mutations in either BRCA1, BRCA2, or ATM",
"criterion": "gene mutations",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"BRCA1",
"BRCA2",
"ATM"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "metastatic hormone receptor (HR) prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "metastasis",
"expected_value": true
}
},
{
"exact_snippets": "metastatic hormone receptor (HR) prostate cancer",
"criterion": "prostate cancer",
"requirement": {
"requirement_type": "hormone receptor status",
"expected_value": "positive"
}
}
]
},
{
"exact_snippets": "mutations in either BRCA1, BRCA2, or ATM",
"criterion": "gene mutations",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"BRCA1",
"BRCA2",
"ATM"
]
}
}
]
}
},
{
"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"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter (6 weeks for nitrosoureas or mitomycin C). Patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be >= 1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events",
"criterions": [
{
"exact_snippets": "Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter",
"criterion": "recent chemotherapy or radiotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "6 weeks for nitrosoureas or mitomycin C",
"criterion": "recent nitrosoureas or mitomycin C treatment",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "Patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study",
"criterion": "time since prior administration of a study drug in a phase 0 or equivalent study",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "be >= 1 week from palliative radiation therapy",
"criterion": "time since palliative radiation therapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "week"
}
]
}
}
},
{
"exact_snippets": "Patients must have recovered to eligibility levels from prior toxicity or adverse events",
"criterion": "recovery from prior toxicity or adverse events",
"requirement": {
"requirement_type": "recovery",
"expected_value": "eligibility levels"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter",
"criterion": "recent chemotherapy or radiotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "Patients must have recovered to eligibility levels from prior toxicity or adverse events",
"criterion": "recovery from prior toxicity or adverse events",
"requirement": {
"requirement_type": "recovery",
"expected_value": "eligibility levels"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "6 weeks for nitrosoureas or mitomycin C",
"criterion": "recent nitrosoureas or mitomycin C treatment",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "Patients must have recovered to eligibility levels from prior toxicity or adverse events",
"criterion": "recovery from prior toxicity or adverse events",
"requirement": {
"requirement_type": "recovery",
"expected_value": "eligibility levels"
}
}
]
}
]
},
{
"exact_snippets": "Patients must be >= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study",
"criterion": "time since prior administration of a study drug in a phase 0 or equivalent study",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "be >= 1 week from palliative radiation therapy",
"criterion": "time since palliative radiation therapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "week"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for >= 1 month without requiring steroid and anti-seizure medication are eligible to participate",
"criterions": [
{
"exact_snippets": "active brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "activity",
"expected_value": false
}
},
{
"exact_snippets": "carcinomatous meningitis",
"criterion": "carcinomatous meningitis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "treated brain metastases ... brain metastatic disease has remained stable for >= 1 month",
"criterion": "treated brain metastases",
"requirement": {
"requirement_type": "stability duration",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
},
{
"exact_snippets": "without requiring steroid and anti-seizure medication",
"criterion": "medication requirement",
"requirement": {
"requirement_type": "medication type",
"expected_value": [
"steroid",
"anti-seizure"
]
}
},
{
"exact_snippets": "without requiring steroid and anti-seizure medication",
"criterion": "medication requirement",
"requirement": {
"requirement_type": "requirement",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "active brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "activity",
"expected_value": false
}
},
{
"exact_snippets": "treated brain metastases ... brain metastatic disease has remained stable for >= 1 month",
"criterion": "treated brain metastases",
"requirement": {
"requirement_type": "stability duration",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "month"
}
}
},
{
"and_criteria": [
{
"exact_snippets": "without requiring steroid and anti-seizure medication",
"criterion": "medication requirement",
"requirement": {
"requirement_type": "medication type",
"expected_value": [
"steroid",
"anti-seizure"
]
}
},
{
"exact_snippets": "without requiring steroid and anti-seizure medication",
"criterion": "medication requirement",
"requirement": {
"requirement_type": "requirement",
"expected_value": false
}
}
]
}
]
},
{
"exact_snippets": "carcinomatous meningitis",
"criterion": "carcinomatous meningitis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib will be determined following review by the principal investigator",
"criterions": [
{
"exact_snippets": "receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib",
"criterion": "medications or substances affecting talazoparib",
"requirement": {
"requirement_type": "potential to affect activity or pharmacokinetics",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib",
"criterion": "medications or substances affecting talazoparib",
"requirement": {
"requirement_type": "potential to affect activity or pharmacokinetics",
"expected_value": true
}
}
},
{
"exact_snippets": "Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib will be determined following review by the principal investigator",
"criterion": "review by principal investigator",
"requirement": {
"requirement_type": "determination",
"expected_value": "required"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements",
"criterions": [
{
"exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
"criterion": "intercurrent illness",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "ongoing or active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "status",
"expected_value": [
"ongoing",
"active"
]
}
},
{
"exact_snippets": "symptomatic congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "symptoms",
"expected_value": "symptomatic"
}
},
{
"exact_snippets": "unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "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 compliance with study requirements"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
"criterion": "intercurrent illness",
"requirement": {
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "ongoing or active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "status",
"expected_value": [
"ongoing",
"active"
]
}
}
]
},
{
"exact_snippets": "symptomatic congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "symptoms",
"expected_value": "symptomatic"
}
},
{
"exact_snippets": "unstable angina pectoris",
"criterion": "angina pectoris",
"requirement": {
"requirement_type": "stability",
"expected_value": "unstable"
}
},
{
"exact_snippets": "cardiac arrhythmia",
"criterion": "cardiac arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "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 compliance with study requirements"
}
}
]
}
},
{
"identified_line": {
"line": "* Pregnant women are excluded from this study because the effects of the study drugs on the developing fetus are unknown",
"criterions": [
{
"exact_snippets": "Pregnant women are excluded",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pregnant women are excluded",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial",
"criterions": [
{
"exact_snippets": "Human immunodeficiency virus (HIV)-infected",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "effective anti-retroviral therapy",
"criterion": "anti-retroviral therapy",
"requirement": {
"requirement_type": "effectiveness",
"expected_value": true
}
},
{
"exact_snippets": "undetectable viral load within 6 months",
"criterion": "viral load",
"requirement": {
"requirement_type": "detectability",
"expected_value": false
}
},
{
"exact_snippets": "undetectable viral load within 6 months",
"criterion": "viral load",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 6 months"
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"exact_snippets": "Human immunodeficiency virus (HIV)-infected",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "effective anti-retroviral therapy",
"criterion": "anti-retroviral therapy",
"requirement": {
"requirement_type": "effectiveness",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "undetectable viral load within 6 months",
"criterion": "viral load",
"requirement": {
"requirement_type": "detectability",
"expected_value": false
}
},
{
"exact_snippets": "undetectable viral load within 6 months",
"criterion": "viral load",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 6 months"
}
}
]
}
]
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "Human immunodeficiency virus (HIV)-infected",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded. Low-dose warfarin (=< 1 mg/day) is permitted",
"criterions": [
{
"exact_snippets": "require use of coumarin-derivative anticoagulants such as warfarin",
"criterion": "use of coumarin-derivative anticoagulants",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Low-dose warfarin (=< 1 mg/day) is permitted",
"criterion": "low-dose warfarin",
"requirement": {
"requirement_type": "dosage",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "mg/day"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "require use of coumarin-derivative anticoagulants such as warfarin",
"criterion": "use of coumarin-derivative anticoagulants",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "require use of coumarin-derivative anticoagulants such as warfarin",
"criterion": "use of coumarin-derivative anticoagulants",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Low-dose warfarin (=< 1 mg/day) is permitted",
"criterion": "low-dose warfarin",
"requirement": {
"requirement_type": "dosage",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "mg/day"
}
}
}
]
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Women who are currently lactating",
"criterions": [
{
"exact_snippets": "Women who are currently lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "status",
"expected_value": "currently lactating"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women who are currently lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "status",
"expected_value": "currently lactating"
}
}
]
}
},
{
"identified_line": {
"line": "* History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled",
"criterions": [
{
"exact_snippets": "History of prior malignancies within the past 3 years",
"criterion": "prior malignancies",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "years"
}
}
},
{
"exact_snippets": "other than non-melanomatous skin cancers",
"criterion": "non-melanomatous skin cancers",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
},
{
"exact_snippets": "that have been controlled",
"criterion": "control status of non-melanomatous skin cancers",
"requirement": {
"requirement_type": "control status",
"expected_value": "controlled"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "History of prior malignancies within the past 3 years",
"criterion": "prior malignancies",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "years"
}
}
},
{
"not_criteria": {
"exact_snippets": "other than non-melanomatous skin cancers",
"criterion": "non-melanomatous skin cancers",
"requirement": {
"requirement_type": "exclusion",
"expected_value": true
}
}
}
]
}
}
]
},
{
"not_criteria": {
"exact_snippets": "that have been controlled",
"criterion": "control status of non-melanomatous skin cancers",
"requirement": {
"requirement_type": "control status",
"expected_value": "controlled"
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Patients who have had prior treatment with talazoparib are ineligible",
"criterions": [
{
"exact_snippets": "prior treatment with talazoparib",
"criterion": "prior treatment with talazoparib",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "prior treatment with talazoparib",
"criterion": "prior treatment with talazoparib",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have had prior monoclonal antibody therapy must have completed that therapy >= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment) except for monoclonal antibody therapies that have been proven to be safe when combined with PARP inhibitor (PARPi) treatment (such as anti-PD-1/PD-L1 and anti-HER2), which must be completed >= 4 weeks prior to enrollment",
"criterions": [
{
"exact_snippets": "Patients who have had prior monoclonal antibody therapy",
"criterion": "prior monoclonal antibody therapy",
"requirement": {
"requirement_type": "completion time",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "3 half-lives of the antibody, whichever is shorter",
"criterion": "half-lives of the antibody",
"requirement": {
"requirement_type": "completion time",
"expected_value": "3 half-lives"
}
},
{
"exact_snippets": "minimum of 1 week between prior therapy and study enrollment",
"criterion": "time between prior therapy and study enrollment",
"requirement": {
"requirement_type": "minimum time",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "week"
}
]
}
}
},
{
"exact_snippets": "monoclonal antibody therapies that have been proven to be safe when combined with PARP inhibitor (PARPi) treatment",
"criterion": "monoclonal antibody therapies safe with PARP inhibitor",
"requirement": {
"requirement_type": "safety",
"expected_value": true
}
},
{
"exact_snippets": "anti-PD-1/PD-L1 and anti-HER2",
"criterion": "specific monoclonal antibody therapies",
"requirement": {
"requirement_type": "types",
"expected_value": [
"anti-PD-1/PD-L1",
"anti-HER2"
]
}
},
{
"exact_snippets": "must be completed >= 4 weeks prior to enrollment",
"criterion": "completion time for specific monoclonal antibody therapies",
"requirement": {
"requirement_type": "completion time",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 4,
"unit": "weeks"
}
]
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients who are receiving any other investigational agents",
"criterions": [
{
"exact_snippets": "Patients who are receiving any other investigational agents",
"criterion": "investigational agents",
"requirement": {
"requirement_type": "receiving",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}