{
"info": {
"nct_id": "NCT01987362",
"official_title": "A Two-Part, Phase I, Multicenter, Open-Label Study of RO6870810/TEN-010 Given Subcutaneously: Part A: A Dose-Escalation Study in Patients With Advanced Solid Tumors. Part B: An Expansion Cohort in Patients With Selected Malignancies",
"inclusion_criteria": "General:\n\n* Participants with solid tumors must have one or more metastatic tumors evaluable or measurable on radiographic imaging\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 2 upon approval by the medical monitor)\n* Life expectancy of greater than or equal to (>/=) 3 months\n* Disease-free of active second/secondary or prior malignancies >/= 2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast\n* Adequate hematological, renal, hepatic and coagulation laboratory test results\n* Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug\n\nAdvanced Solid Malignancies:\n\n* Participants with previously treated, histologically confirmed advanced solid malignancy with progressive disease requiring therapy\n* Participants must be refractory or intolerant to standard therapy\n\nNUT-midline carcinoma:\n\n* Participants with histologically confirmed newly diagnosed or relapsed/refractory NMC with PD requiring therapy\n* Diagnosis of one of the following is required:\n\n 1. NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by Immunohistochemistry (IHC) and/or;\n 2. Detection of NUT gene translocation as determined by Fluorescence In-Situ Hybridization (FISH) Advanced Aggressive DLBCL\n* Histologically confirmed advanced aggressive B-cell lymphoma with abnormal MYC expression with persistent disease requiring treatment\n* Participants must have relapsed or progressed after at least 2 lines of prior therapy and not eligible for any curative treatment\n* Participants must have measurable disease\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Participants with hematologic malignancies\n* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia\n* Have Fridericia-corrected QT interval (QTcF) greater than (>) 470 milliseconds (msec) (female) or > 450 (male), or history of congenital long QT syndrome\n* Active, uncontrolled bacterial, viral, or fungal infections\n* Known clinically important respiratory impairment\n* Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies\n* History of major organ transplant\n* History of an autologous or allogeneic bone marrow transplant. For DLBCL participants only: DLBCL participants may have had a previous autologous transplant but not within 90 days of study entry\n* Symptomatic central nervous system malignancy or metastasis\n* Pregnant or nursing\n* Treatment with surgery or chemotherapy within 28 days prior to study entry\n* Prior treatment with small molecule (BET) family inhibitor\n* Radiation for symptomatic lesions within 14 days of study enrollment",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Participants with solid tumors must have one or more metastatic tumors evaluable or measurable on radiographic imaging",
"criterions": [
{
"exact_snippets": "solid tumors",
"criterion": "solid tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "metastatic tumors evaluable or measurable on radiographic imaging",
"criterion": "metastatic tumors",
"requirements": [
{
"requirement_type": "evaluable or measurable",
"expected_value": true
}
]
}
]
},
{
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 2 upon approval by the medical monitor)",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 2 upon approval by the medical monitor)",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"0",
"1",
"2 upon approval by the medical monitor"
]
}
]
}
]
},
{
"line": "* Life expectancy of greater than or equal to (>/=) 3 months",
"criterions": [
{
"exact_snippets": "Life expectancy of greater than or equal to (>/=) 3 months",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Disease-free of active second/secondary or prior malignancies >/= 2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast",
"criterions": [
{
"exact_snippets": "Disease-free of active second/secondary or prior malignancies >/= 2 years",
"criterion": "active second/secondary or prior malignancies",
"requirements": [
{
"requirement_type": "disease-free duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast",
"criterion": "currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in-situ\" of the cervix or breast",
"requirements": [
{
"requirement_type": "exception",
"expected_value": true
}
]
}
]
},
{
"line": "* Adequate hematological, renal, hepatic and coagulation laboratory test results",
"criterions": [
{
"exact_snippets": "Adequate hematological ... laboratory test results",
"criterion": "hematological laboratory test results",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... renal ... laboratory test results",
"criterion": "renal laboratory test results",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... hepatic ... laboratory test results",
"criterion": "hepatic laboratory test results",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... coagulation laboratory test results",
"criterion": "coagulation laboratory test results",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug",
"criterions": [
{
"exact_snippets": "Women of child bearing potential",
"criterion": "women of child bearing potential",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "men must agree to use adequate contraception",
"criterion": "men contraception agreement",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": true
}
]
},
{
"exact_snippets": "Women of child bearing potential and men must agree to use adequate contraception during the study and for 4 months after the last dose of study drug",
"criterion": "contraception duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "during the study and for 4 months after the last dose of study drug"
}
]
}
]
},
{
"line": "Advanced Solid Malignancies:",
"criterions": [
{
"exact_snippets": "Advanced Solid Malignancies",
"criterion": "solid malignancies",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "advanced"
}
]
}
]
},
{
"line": "* Participants with previously treated, histologically confirmed advanced solid malignancy with progressive disease requiring therapy",
"criterions": [
{
"exact_snippets": "previously treated",
"criterion": "treatment history",
"requirements": [
{
"requirement_type": "status",
"expected_value": "previously treated"
}
]
},
{
"exact_snippets": "histologically confirmed",
"criterion": "diagnosis confirmation",
"requirements": [
{
"requirement_type": "method",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "advanced solid malignancy",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "advanced"
},
{
"requirement_type": "type",
"expected_value": "solid malignancy"
}
]
},
{
"exact_snippets": "progressive disease",
"criterion": "disease progression",
"requirements": [
{
"requirement_type": "status",
"expected_value": "progressive"
}
]
},
{
"exact_snippets": "requiring therapy",
"criterion": "treatment necessity",
"requirements": [
{
"requirement_type": "necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Participants must be refractory or intolerant to standard therapy",
"criterions": [
{
"exact_snippets": "refractory ... to standard therapy",
"criterion": "refractory to standard therapy",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "intolerant to standard therapy",
"criterion": "intolerant to standard therapy",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
}
]
},
{
"line": "NUT-midline carcinoma:",
"criterions": [
{
"exact_snippets": "NUT-midline carcinoma",
"criterion": "NUT-midline carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Participants with histologically confirmed newly diagnosed or relapsed/refractory NMC with PD requiring therapy",
"criterions": [
{
"exact_snippets": "histologically confirmed newly diagnosed or relapsed/refractory NMC",
"criterion": "NMC diagnosis",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": true
},
{
"requirement_type": "status",
"expected_value": [
"newly diagnosed",
"relapsed/refractory"
]
}
]
},
{
"exact_snippets": "PD requiring therapy",
"criterion": "PD",
"requirements": [
{
"requirement_type": "treatment necessity",
"expected_value": true
}
]
}
]
},
{
"line": "* Diagnosis of one of the following is required:",
"criterions": [
{
"exact_snippets": "Diagnosis of one of the following is required",
"criterion": "diagnosis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "1. NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by Immunohistochemistry (IHC) and/or;",
"criterions": [
{
"exact_snippets": "NUT Midline Carcinoma based on ectopic expression of NUT protein",
"criterion": "NUT Midline Carcinoma",
"requirements": [
{
"requirement_type": "expression",
"expected_value": "ectopic"
}
]
},
{
"exact_snippets": "NUT protein as determined by Immunohistochemistry (IHC)",
"criterion": "NUT protein",
"requirements": [
{
"requirement_type": "determination method",
"expected_value": "Immunohistochemistry (IHC)"
}
]
}
]
},
{
"line": "2. Detection of NUT gene translocation as determined by Fluorescence In-Situ Hybridization (FISH) Advanced Aggressive DLBCL",
"criterions": [
{
"exact_snippets": "Detection of NUT gene translocation",
"criterion": "NUT gene translocation",
"requirements": [
{
"requirement_type": "detection",
"expected_value": true
}
]
},
{
"exact_snippets": "Advanced Aggressive DLBCL",
"criterion": "Advanced Aggressive DLBCL",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Histologically confirmed advanced aggressive B-cell lymphoma with abnormal MYC expression with persistent disease requiring treatment",
"criterions": [
{
"exact_snippets": "Histologically confirmed advanced aggressive B-cell lymphoma",
"criterion": "B-cell lymphoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
},
{
"requirement_type": "stage",
"expected_value": "advanced"
},
{
"requirement_type": "aggressiveness",
"expected_value": "aggressive"
}
]
},
{
"exact_snippets": "abnormal MYC expression",
"criterion": "MYC expression",
"requirements": [
{
"requirement_type": "expression status",
"expected_value": "abnormal"
}
]
},
{
"exact_snippets": "persistent disease requiring treatment",
"criterion": "disease persistence",
"requirements": [
{
"requirement_type": "persistence",
"expected_value": true
},
{
"requirement_type": "treatment requirement",
"expected_value": true
}
]
}
]
},
{
"line": "* Participants must have relapsed or progressed after at least 2 lines of prior therapy and not eligible for any curative treatment",
"criterions": [
{
"exact_snippets": "relapsed or progressed",
"criterion": "disease status",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"relapsed",
"progressed"
]
}
]
},
{
"exact_snippets": "after at least 2 lines of prior therapy",
"criterion": "prior therapy",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "lines"
}
}
]
},
{
"exact_snippets": "not eligible for any curative treatment",
"criterion": "curative treatment eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": false
}
]
}
]
},
{
"line": "* Participants must have measurable disease",
"criterions": [
{
"exact_snippets": "Participants must have measurable disease",
"criterion": "disease",
"requirements": [
{
"requirement_type": "measurability",
"expected_value": true
}
]
}
]
},
{
"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": "* Participants with hematologic malignancies",
"criterions": [
{
"exact_snippets": "hematologic malignancies",
"criterion": "hematologic malignancies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia",
"criterions": [
{
"exact_snippets": "New York Heart Association Class III or IV",
"criterion": "New York Heart Association class",
"requirements": [
{
"requirement_type": "severity",
"expected_value": [
"III",
"IV"
]
}
]
},
{
"exact_snippets": "cardiac disease",
"criterion": "cardiac disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "myocardial infarction within the past 6 months",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
]
},
{
"exact_snippets": "unstable arrhythmia",
"criterion": "unstable arrhythmia",
"requirements": [
{
"requirement_type": "stability",
"expected_value": "unstable"
}
]
}
]
},
{
"line": "* Have Fridericia-corrected QT interval (QTcF) greater than (>) 470 milliseconds (msec) (female) or > 450 (male), or history of congenital long QT syndrome",
"criterions": [
{
"exact_snippets": "Fridericia-corrected QT interval (QTcF) greater than (>) 470 milliseconds (msec) (female)",
"criterion": "Fridericia-corrected QT interval (QTcF)",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 470,
"unit": "milliseconds"
}
}
]
},
{
"exact_snippets": "Fridericia-corrected QT interval (QTcF) ... > 450 (male)",
"criterion": "Fridericia-corrected QT interval (QTcF)",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 450,
"unit": "milliseconds"
}
}
]
},
{
"exact_snippets": "history of congenital long QT syndrome",
"criterion": "congenital long QT syndrome",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Active, uncontrolled bacterial, viral, or fungal infections",
"criterions": [
{
"exact_snippets": "Active, uncontrolled bacterial ... infections",
"criterion": "bacterial infections",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
},
{
"requirement_type": "activity status",
"expected_value": "active"
}
]
},
{
"exact_snippets": "Active, uncontrolled ... viral ... infections",
"criterion": "viral infections",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
},
{
"requirement_type": "activity status",
"expected_value": "active"
}
]
},
{
"exact_snippets": "Active, uncontrolled ... fungal infections",
"criterion": "fungal infections",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
},
{
"requirement_type": "activity status",
"expected_value": "active"
}
]
}
]
},
{
"line": "* Known clinically important respiratory impairment",
"criterions": [
{
"exact_snippets": "Known clinically important respiratory impairment",
"criterion": "respiratory impairment",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "clinically important"
},
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies",
"criterions": [
{
"exact_snippets": "Positive for human immunodeficiency virus (HIV)",
"criterion": "HIV status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Positive for ... hepatitis B surface antigen",
"criterion": "hepatitis B surface antigen",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Positive for ... hepatitis C antibodies",
"criterion": "hepatitis C antibodies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of major organ transplant",
"criterions": [
{
"exact_snippets": "History of major organ transplant",
"criterion": "major organ transplant",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* History of an autologous or allogeneic bone marrow transplant. For DLBCL participants only: DLBCL participants may have had a previous autologous transplant but not within 90 days of study entry",
"criterions": [
{
"exact_snippets": "History of an autologous or allogeneic bone marrow transplant",
"criterion": "bone marrow transplant",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "DLBCL participants may have had a previous autologous transplant",
"criterion": "autologous transplant for DLBCL participants",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "not within 90 days of study entry",
"criterion": "autologous transplant timing for DLBCL participants",
"requirements": [
{
"requirement_type": "timing",
"expected_value": {
"operator": ">",
"value": 90,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Symptomatic central nervous system malignancy or metastasis",
"criterions": [
{
"exact_snippets": "Symptomatic central nervous system malignancy",
"criterion": "central nervous system malignancy",
"requirements": [
{
"requirement_type": "symptomatic",
"expected_value": true
}
]
},
{
"exact_snippets": "Symptomatic ... metastasis",
"criterion": "metastasis",
"requirements": [
{
"requirement_type": "symptomatic",
"expected_value": true
}
]
}
]
},
{
"line": "* Pregnant or nursing",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "nursing",
"criterion": "nursing status",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Treatment with surgery or chemotherapy within 28 days prior to study entry",
"criterions": [
{
"exact_snippets": "Treatment with surgery ... within 28 days prior to study entry",
"criterion": "surgery treatment",
"requirements": [
{
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
]
},
{
"exact_snippets": "Treatment with ... chemotherapy within 28 days prior to study entry",
"criterion": "chemotherapy treatment",
"requirements": [
{
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Prior treatment with small molecule (BET) family inhibitor",
"criterions": [
{
"exact_snippets": "Prior treatment with small molecule (BET) family inhibitor",
"criterion": "prior treatment",
"requirements": [
{
"requirement_type": "treatment type",
"expected_value": "small molecule (BET) family inhibitor"
}
]
}
]
},
{
"line": "* Radiation for symptomatic lesions within 14 days of study enrollment",
"criterions": [
{
"exact_snippets": "Radiation for symptomatic lesions within 14 days of study enrollment",
"criterion": "radiation for symptomatic lesions",
"requirements": [
{
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 14,
"unit": "days"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "General:",
"criterions": []
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}