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NCT04388475 · ClinicalTrials.gov registry record · Phase 2
Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma
A Phase 2 study, sponsored by Oblato.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT04388475 is a Phase 2 study that has completed, run by Oblato. The registered enrollment target is 57 participants.
The verdict
NCT04388475, a Phase 2 study, has completed, sponsored by Oblato.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease. Patients with unequivocal recurrence (first or greater) established by MRI and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.
Interventions
- DRUG Temozolomide (TMZ)
- DRUG OKN-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2020-06-12 |
| Est. Completion | 2025-03-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04388475
The ClinicalTrials.gov registry entry for NCT04388475 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oblato, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temozolomide (TMZ) is the first listed.
NCT04388475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04388475 about?
NCT04388475 is a clinical study titled "Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma". This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic(PK) properties of OKN-007 combined with temozolomide(TMZ) in patients with recurrent glioblastoma(GBM). All patients will have been previously treated with the standard-of-care treatment which includes surgica...
What is the current status of trial NCT04388475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2020-06-12. Estimated completion is 2025-03-05.
What interventions are being tested in trial NCT04388475?
The interventions under investigation include: Temozolomide (TMZ) (DRUG), OKN-007 (DRUG).
Who is sponsoring clinical trial NCT04388475?
This trial is sponsored by Oblato, which has 2 total clinical trials registered on ClinicalTrials.gov.
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