{
    "info": {
        "nct_id": "NCT02499120",
        "official_title": "A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 2 STUDY OF PALBOCICLIB PLUS CETUXIMAB VERSUS CETUXIMAB FOR THE TREATMENT OF HUMAN PAPILLOMAVIRUS-NEGATIVE, CETUXIMAB-NAÏVE PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AFTER FAILURE OF ONE PRIOR PLATINUM-CONTAINING CHEMOTHERAPY REGIMEN",
        "inclusion_criteria": "* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.\n* Measurable disease as defined per RECIST v. 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.\n* HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC; multiplex nucleic acid sequence based amplification [NASBA] or other polymerase chain reaction [PCR]-based assays).\n* Documented progressive disease according to RECIST v1.1 (Appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [AUC] > 4 for carboplatin).\n* Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.\n\nKey\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior nasopharyngeal cancer, salivary gland or sinus tumors.\n* More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.\n* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.\n* Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN.\n* Difficulty swallowing capsules.\n* Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)",
        "miscellaneous_criteria": "Key"
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "hypopharynx",
                                "larynx"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable for salvage surgery or radiotherapy",
                    "criterion": "treatment amenability",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease as defined per RECIST v. 1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease as defined per RECIST v. 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v. 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease progression at the treated site after completion of therapy is clearly documented.",
                    "criterion": "tumor lesions previously treated",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "disease progression at the treated site after completion of therapy is clearly documented"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HPV- negative SCCHN tumor as determined per institutional standard (eg, p16 IHC; multiplex nucleic acid sequence based amplification [NASBA] or other polymerase chain reaction [PCR]-based assays).",
            "criterions": [
                {
                    "exact_snippets": "HPV- negative SCCHN tumor",
                    "criterion": "HPV status of SCCHN tumor",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented progressive disease according to RECIST v1.1 (Appendix 2) following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen administered for R/M disease (min. 50 mg/m2 for cisplatin, minimum area under the curve [AUC] > 4 for carboplatin).",
            "criterions": [
                {
                    "exact_snippets": "Documented progressive disease according to RECIST v1.1",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "following receipt of at least 2 cycles of one platinum-containing chemotherapy regimen",
                    "criterion": "platinum-containing chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "cycles",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "min. 50 mg/m2 for cisplatin",
                    "criterion": "cisplatin dosage",
                    "requirements": [
                        {
                            "requirement_type": "minimum dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "minimum area under the curve [AUC] > 4 for carboplatin",
                    "criterion": "carboplatin AUC",
                    "requirements": [
                        {
                            "requirement_type": "minimum AUC",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides]), which will be used for centralized, retrospective biomarker analysis. If archived tumor tissue is not available, then a de novo biopsy will be required for patient participation.",
            "criterions": [
                {
                    "exact_snippets": "Availability of a tumor tissue specimen (ie, archived formalin fixed paraffin embedded tissue [block preferred, or 15 unstained slides])",
                    "criterion": "tumor tissue specimen",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "If archived tumor tissue is not available, then a de novo biopsy will be required",
                    "criterion": "de novo biopsy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "required if archived tumor tissue is not available"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior nasopharyngeal cancer, salivary gland or sinus tumors.",
            "criterions": [
                {
                    "exact_snippets": "Prior nasopharyngeal cancer",
                    "criterion": "nasopharyngeal cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "salivary gland ... tumors",
                    "criterion": "salivary gland tumors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sinus tumors",
                    "criterion": "sinus tumors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than one chemotherapeutic regimen given for R/M disease. Prior treatment with immunotherapy is allowed.",
            "criterions": [
                {
                    "exact_snippets": "More than one chemotherapeutic regimen given for R/M disease.",
                    "criterion": "chemotherapeutic regimen for R/M disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with immunotherapy is allowed.",
                    "criterion": "prior treatment with immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization.",
            "criterions": [
                {
                    "exact_snippets": "Known active uncontrolled or symptomatic central nervous system (CNS) metastases",
                    "criterion": "active CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (eg, radiotherapy, stereotactic surgery)",
                    "criterion": "history of CNS metastases or cord compression",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "definitively treated with local therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically stable off anticonvulsants and steroids for at least 4 weeks before randomization",
                    "criterion": "clinical stability off anticonvulsants and steroids",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive disease within 3 months after completion of curatively intended treatment for locoregionally advanced SCCHN.",
            "criterions": [
                {
                    "exact_snippets": "Progressive disease within 3 months after completion of curatively intended treatment",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively intended treatment for locoregionally advanced SCCHN",
                    "criterion": "treatment type",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "locoregionally advanced SCCHN"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Difficulty swallowing capsules.",
            "criterions": [
                {
                    "exact_snippets": "Difficulty swallowing capsules.",
                    "criterion": "swallowing ability",
                    "requirements": [
                        {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior use of cetuximab in the R/M disease treatment setting (except cetuximab during curative radiotherapy)",
            "criterions": [
                {
                    "exact_snippets": "Prior use of cetuximab in the R/M disease treatment setting",
                    "criterion": "prior use of cetuximab",
                    "requirements": [
                        {
                            "requirement_type": "treatment setting",
                            "expected_value": "R/M disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "except cetuximab during curative radiotherapy",
                    "criterion": "use of cetuximab",
                    "requirements": [
                        {
                            "requirement_type": "treatment setting",
                            "expected_value": "curative radiotherapy"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key",
            "criterions": [
                {
                    "exact_snippets": "Tissue from tumor must be available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Tissue from tumor ... > 2 cm in diameter.",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        }
    ]
}