Trial Outcomes & Findings for A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma (NCT NCT00479765)

Results Overview

any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

8 weeks

Results posted on

2022-06-22

Participant milestones
Measure	OncoGel OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal
Measure	OncoGel OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
Overall Study study terminated	4

A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma

Baseline characteristics by cohort
Measure	OncoGel 5mL n=4 Participants OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
Age, Continuous	60 years n=39 Participants
Sex: Female, Male Female	0 Participants n=39 Participants
Sex: Female, Male Male	4 Participants n=39 Participants

Timeframe: 8 weeks

any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)

Outcome measures
Measure	OncoGel 5mL n=4 Participants OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
Occurence of Dose-limiting Toxicities (DLTs)	0 dose limiting toxicities

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	OncoGel 5mL n=4 participants at risk OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
Vascular disorders subdural hematoma	50.0% 2/4 • Number of events 2

Adverse event data not reported

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