Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2023-01-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2023-02-13"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2023-01-16"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/description",
"value": "A polymer micelle covalently conjugated to indocyanine green."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "<p>Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose.</p><p>Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma [NSCLC]).</p><p>Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery.</p>"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"value": {
"resetReasons": [
"More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"value": "Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
"value": "Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Evaluate Pharmacokinetic Parameters: Cmax"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Evaluate Pharmacokinetic Parameters: Tmax"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Evaluate Pharmacokinetic Parameters: AUC"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Evaluate Pharmacokinetic Parameters: CL"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Evaluate Pharmacokinetic Parameters: Vz"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Evaluate Pharmacokinetic Parameters: t1/2"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "Evaluate the Terminal elimination half-life [t1/2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "clinicaltrials@onconanomed.com",
"phone": "682-285-1411",
"title": "Vice President, Clinical Operations",
"organization": "OncoNano Medicine, Inc."
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": false
}
},
"adverseEventsModule": {
"timeFrame": "Adverse events were collected from the time of study drug administration throughout the course of the study. The total collection period for each subject was approximately one month.",
"eventGroups": [
{
"id": "EG000",
"title": "Patients Receiving ONM-100",
"description": "<p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to an ICG-like moiety.</p>",
"otherNumAtRisk": 30,
"deathsNumAtRisk": 30,
"otherNumAffected": 30,
"seriousNumAtRisk": 30,
"deathsNumAffected": 0,
"seriousNumAffected": 6
}
],
"otherEvents": [
{
"term": "Infusion-related reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 17,
"numAffected": 17
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Buttock injury",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Neck injury",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Wound",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Oral pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Neck pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Myalgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Muscle spasms",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Musculoskeletal stiffness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Pain in extremity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Injection site reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Malaise",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Pyrexia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Nervous system disorders",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Dizziness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Sensory disturbance",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Procedural pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
}
],
"seriousEvents": [
{
"term": "Cellulitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Superficial Vein Thrombosis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Abscess Neck",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Thrombophlebitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Tonsillar Hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
},
{
"term": "Infusion Related Reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 30,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "MedDRA (19.0)"
}
],
"armsReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
},
"frequencyThreshold": "0"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "3",
"groupId": "OG001"
},
{
"value": "2",
"groupId": "OG002"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "ONM-100 at a Dose of 1 mg/kg",
"description": "All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg."
},
{
"id": "OG001",
"title": "ONM-100 at a Dose of 3 mg/kg",
"description": "All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg."
},
{
"id": "OG002",
"title": "ONM-100 at a Dose of 2 mg/kg",
"description": "All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "2.858",
"spread": "2.2128",
"groupId": "OG000"
},
{
"value": "3.498",
"spread": "1.3717",
"groupId": "OG001"
},
{
"value": "2.608",
"spread": "2.5936",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "MEAN",
"timeFrame": "1 day",
"reviewUnit": {
"resetReasons": [
"More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent."
]
},
"description": "<p>Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose.</p><p>Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma [NSCLC]).</p><p>Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery.</p>",
"unitOfMeasure": "units on a scale",
"dispersionType": "Standard Deviation",
"reportingStatus": "POSTED",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The Unit of Measure appears inconsistent with the Measure Title, the Measure Description, or both."
]
}
},
{
"type": "PRIMARY",
"title": "Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "30",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Patients Receiving ONM-100",
"description": "<p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to IGC.</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "26",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "28 days",
"description": "Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"measureCategoriesReviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
},
{
"type": "SECONDARY",
"title": "Evaluate Pharmacokinetic Parameters: Cmax",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "9",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
},
{
"value": "6",
"groupId": "OG002"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "ONM-100 at a Dose of 1 mg/kg",
"description": "All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg."
},
{
"id": "OG001",
"title": "ONM-100 at a Dose of 2 mg/kg",
"description": "All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg."
},
{
"id": "OG002",
"title": "ONM-100 at a Dose of 3 mg/kg",
"description": "All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "26.5",
"spread": "16.0",
"groupId": "OG000"
},
{
"value": "52.2",
"spread": "13.0",
"groupId": "OG001"
},
{
"value": "79.5",
"spread": "30.0",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "6 days",
"description": "Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
"unitOfMeasure": "μg/mL",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "The PK analysis population is comprised 19 patients for whom concentration data were available.\nDue to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients."
},
{
"type": "SECONDARY",
"title": "Evaluate Pharmacokinetic Parameters: Tmax",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "9",
"groupId": "OG000"
},
{
"value": "4",
"groupId": "OG001"
},
{
"value": "6",
"groupId": "OG002"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "ONM-100 at Dose of 1 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 1 mg/kg."
},
{
"id": "OG001",
"title": "ONM-100 at a Dose of 2 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 2 mg/kg."
},
{
"id": "OG002",
"title": "ONM-100 at a Dose of 3 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 3 mg/kg."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "0.25",
"groupId": "OG000",
"lowerLimit": "0.22",
"upperLimit": "1.12"
},
{
"value": "0.31",
"groupId": "OG001",
"lowerLimit": "0.27",
"upperLimit": "7.35"
},
{
"value": "0.31",
"groupId": "OG002",
"lowerLimit": "0.23",
"upperLimit": "0.37"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "6 days",
"description": "Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
"unitOfMeasure": "hr",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients."
},
{
"type": "SECONDARY",
"title": "Evaluate Pharmacokinetic Parameters: AUC",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "9",
"groupId": "OG000"
},
{
"value": "3",
"groupId": "OG001"
},
{
"value": "6",
"groupId": "OG002"
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]
}
],
"groups": [
{
"id": "OG000",
"title": "ONM-100 at a Dose of 1 mg/kg",
"description": "Patients receiving a single IV administration of ONM-100 at 1 mg/kg."
},
{
"id": "OG001",
"title": "ONM-100 at a Dose of 2 mg/kg",
"description": "Patients received a single IV administration of ONM-100 at 2 mg/kg."
},
{
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"title": "ONM-100 at a Dose of 3 mg/kg",
"description": "Patients receiving a single IV administration of ONM-100 at 3 mg/kg."
}
],
"classes": [
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"categories": [
{
"measurements": [
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"value": "433",
"spread": "127",
"groupId": "OG000"
},
{
"value": "1509",
"spread": "80.1",
"groupId": "OG001"
},
{
"value": "2067",
"spread": "38.4",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "6 days",
"description": "Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
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"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients."
},
{
"type": "SECONDARY",
"title": "Evaluate Pharmacokinetic Parameters: CL",
"denoms": [
{
"units": "Participants",
"counts": [
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"groupId": "OG000"
},
{
"value": "0",
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{
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"groupId": "OG002"
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}
],
"groups": [
{
"id": "OG000",
"title": "ONM-100 at a Dose of 1 mg/kg",
"description": "Patients receiving a single IV administration of ONM-100 at 1 mg/kg."
},
{
"id": "OG001",
"title": "ONM-100 at a Dose of 2 mg/kg",
"description": "Patients received a single IV administration of ONM-100 at 2 mg/kg."
},
{
"id": "OG002",
"title": "ONM-100 at a Dose of 3 mg/kg",
"description": "Patients receiving a single IV administration of ONM-100 at 3 mg/kg."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "0.053",
"spread": "2.57",
"groupId": "OG000"
},
{
"value": "0.053",
"spread": "70.5",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "6 days",
"description": "Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
"unitOfMeasure": "L/hr",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to the sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients."
},
{
"type": "SECONDARY",
"title": "Evaluate Pharmacokinetic Parameters: Vz",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
},
{
"value": "2",
"groupId": "OG002"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "ONM-100 at Dose of 1 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 1 mg/kg."
},
{
"id": "OG001",
"title": "ONM-100 at a Dose of 2 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 2 mg/kg."
},
{
"id": "OG002",
"title": "ONM-100 at a Dose of 3 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 3 mg/kg."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "3.78",
"spread": "33.9",
"groupId": "OG000"
},
{
"value": "5.32",
"spread": "82.9",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "6 days",
"description": "Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
"unitOfMeasure": "L",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients."
},
{
"type": "SECONDARY",
"title": "Evaluate Pharmacokinetic Parameters: t1/2",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "2",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
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{
"value": "2",
"groupId": "OG002"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "ONM-100 at Dose of 1 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 1 mg/kg."
},
{
"id": "OG001",
"title": "ONM-100 at a Dose of 2 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 2 mg/kg."
},
{
"id": "OG002",
"title": "ONM-100 at a Dose of 3 mg/kg",
"description": "All patients in this arm received IV administration of ONM-100 at a dose of 3 mg/kg."
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "49.0",
"spread": "36.7",
"groupId": "OG000"
},
{
"value": "69.4",
"spread": "8.80",
"groupId": "OG002"
}
]
}
]
}
],
"paramType": "GEOMETRIC_MEAN",
"timeFrame": "6 days",
"description": "Evaluate the Terminal elimination half-life [t1/2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
"unitOfMeasure": "hr",
"dispersionType": "Geometric Coefficient of Variation",
"reportingStatus": "POSTED",
"populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to the sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Patients Receiving ONM-100",
"description": "<p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to IGC.</p>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "30"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "27"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "3"
}
]
}
],
"dropWithdraws": [
{
"type": "Withdrawal by Subject",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
]
},
{
"type": "Patient unable or unwilling to continue",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "2"
}
]
}
]
}
],
"reviewUnit": {
"resetReasons": [
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}
},
"baselineCharacteristicsModule": {
"denoms": [
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"counts": [
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"groupId": "BG000"
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]
}
],
"groups": [
{
"id": "BG000",
"title": "Patients Receiving ONM-100",
"description": "<p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to an ICG-like moiety.</p>"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "60.5",
"spread": "8.46",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "8",
"groupId": "BG000"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "22",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Ethnicity (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "Hispanic or Latino",
"measurements": [
{
"value": "3",
"groupId": "BG000"
}
]
},
{
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "25",
"groupId": "BG000"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "2",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "American Indian or Alaska Native",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Asian",
"measurements": [
{
"value": "1",
"groupId": "BG000"
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Black or African American",
"measurements": [
{
"value": "5",
"groupId": "BG000"
}
]
},
{
"title": "White",
"measurements": [
{
"value": "22",
"groupId": "BG000"
}
]
},
{
"title": "More than one race",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "2",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"categories": [
{
"measurements": [
{
"value": "30",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
},
{
"title": "Patients receiving ONM-100",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "30",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
}
],
"reviewUnit": {
"resetReasons": [
"The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
]
}
}
}
},
{
"op": "add",
"path": "/annotationSection",
"value": {
"annotationModule": {
"unpostedAnnotation": {
"unpostedEvents": [
{
"date": "2023-02-10",
"type": "RESET"
}
],
"unpostedResponsibleParty": "OncoNano Medicine, Inc."
}
}
}
},
{
"op": "add",
"path": "/documentSection",
"value": {
"largeDocumentModule": {
"noSap": true,
"largeDocs": [
{
"date": "2020-12-03",
"size": 10719934,
"label": "Study Protocol",
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"hasSap": false,
"filename": "Prot_000.pdf",
"typeAbbrev": "Prot",
"uploadDate": "2023-01-16T16:07",
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