NCT03094169
Version 7 to 8 · Formation Biologics
Patch inspector
Manual review pending.
primary_outcome_any_changesecondary_outcome_any_change [
{
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"signal": "timeline_major_slip",
"category": "timeline_major_slip",
"new_type": "ESTIMATED",
"old_type": "ESTIMATED",
"severity": "medium",
"direction": "later",
"new_value": "2020-09-01",
"old_value": "2019-09-01",
"delta_days": 366,
"date_struct": "primaryCompletionDateStruct",
"new_precision": "day",
"old_precision": "day"
},
{
"path": "/protocolSection/statusModule/completionDateStruct/date",
"signal": "timeline_significant_shift",
"category": "timeline_significant_shift",
"new_type": "ESTIMATED",
"old_type": "ESTIMATED",
"severity": "medium",
"direction": "later",
"new_value": "2020-12-01",
"old_value": "2020-06-01",
"delta_days": 183,
"date_struct": "completionDateStruct",
"new_precision": "day",
"old_precision": "day"
}
] bcdda534b368280dde68c586d813d2ebfa38564d530e8d93d7ce6f8e41733cbe/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. 12 months
18 months
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 9 months
18 months
/protocolSection/statusModule/primaryCompletionDateStruct/date primary_completion_timeline_change Primary completion date changes are operational timeline signals. 2019-09-01
2020-09-01
/protocolSection/statusModule/completionDateStruct/date completion_timeline_change Completion date changes are operational timeline signals. 2020-06-01
2020-12-01
/protocolSection/contactsLocationsModule/locations/3/status NOT_YET_RECRUITING
RECRUITING
/protocolSection/contactsLocationsModule/locations/8/status NOT_YET_RECRUITING
RECRUITING
/protocolSection/contactsLocationsModule/locations/9/status NOT_YET_RECRUITING
RECRUITING
/protocolSection/statusModule/statusVerifiedDate 2019-04
2019-08
/protocolSection/statusModule/lastUpdateSubmitDate 2019-04-03
2019-08-28
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2019-04-05
2019-08-30
/protocolSection/descriptionModule/detailedDescription <p>On Day 1 of study, patients will receive study drug administered by 2-hour IV infusion in a fixed 100 mL volume. AVID100 will be administered once every 3 weeks (Q3W) with administration on Day 1 of the first week, followed by a 3-week recovery period. In Phase 2a AVID100 will be administered at a dose of 220 mg/m2.</p><p>Evidence of progressive disease at any point in the study will necessitate withdrawal of the patient from further participation so that alternative management of their malignancy may be considered. All patients will be followed to further evaluate safety as well as evidence of the anti-tumor effects of AVID100 in these selected patient populations. If anti-tumor activity is observed additional patients may be added to the planned Phase 2a patient populations to further characterize these effects.</p>
<p>On Day 1 of study, patients will receive study drug administered by 2-hour IV infusion. AVID100 will be administered once every 3 weeks (Q3W) with administration on Day 1 of the first week, followed by a 3-week recovery period. In Phase 2a AVID100 will be administered at a dose of 220 mg/m2.</p><p>Evidence of progressive disease at any point in the study will necessitate withdrawal of the patient from further participation so that alternative management of their malignancy may be considered. All patients will be followed to further evaluate safety as well as evidence of the anti-tumor effects of AVID100 in these selected patient populations. If anti-tumor activity is observed additional patients may be added to the planned Phase 2a patient populations to further characterize these effects.</p>
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2019-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2020-09-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2020-12-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2019-08-28"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2019-08-30"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "<p>On Day 1 of study, patients will receive study drug administered by 2-hour IV infusion.\nAVID100 will be administered once every 3 weeks (Q3W) with administration on Day 1 of the first week, followed by a 3-week recovery period.\nIn Phase 2a AVID100 will be administered at a dose of 220 mg/m2.</p><p>Evidence of progressive disease at any point in the study will necessitate withdrawal of the patient from further participation so that alternative management of their malignancy may be considered.\nAll patients will be followed to further evaluate safety as well as evidence of the anti-tumor effects of AVID100 in these selected patient populations.\nIf anti-tumor activity is observed additional patients may be added to the planned Phase 2a patient populations to further characterize these effects.</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"value": "18 months"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "18 months"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/3/status",
"value": "RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/8/status",
"value": "RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/9/status",
"value": "RECRUITING"
}
]