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NCT02303678 · ClinicalTrials.gov registry record · Phase 1
D2C7 for Adult Patients With Recurrent Malignant Glioma
A Phase 1 study, sponsored by Darell Bigner.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT02303678 is a Phase 1 study that has completed, run by Darell Bigner. The registered enrollment target is 81 participants.
The verdict
NCT02303678, a Phase 1 study, has completed, sponsored by Darell Bigner.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This is a Phase I study to determine the maximum tolerated dose (MTD) and/or recommended phase II dose of D2C7-IT (D2C7 Immunotoxin) when delivered intratumorally by convection-enhanced delivery (CED) to recurrent World Health Organization (WHO) grade III and IV malignant glioma patients, and/or to determine what dose will be considered in a Phase II trial. Patients with recurrent WHO grade III and IV malignant glioma who meet eligibility criteria will be enrolled into the study. Immediately following the stereotactically-guided tumor biopsy conducted as standard of care, up to three additional core biopsies will be obtained for molecular genetic testing. After these biopsies are obtained, subjects will have up to 2 catheters inserted. If the biopsy indicates a proven diagnosis of recurrent malignant glioma (diagnosis results are typically received within 24-48 hours following biopsy), the investigators will proceed with the D2C7-IT infusion. If no tumor is identified, the catheters will be removed. A continuous intratumoral infusion of D2C7-IT will be administered over 72 hours while in the hospital.
Interventions
- DRUG D2C7-IT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2015-05-05 |
| Est. Completion | 2024-03-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02303678
The ClinicalTrials.gov registry entry for NCT02303678 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Darell Bigner, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which D2C7-IT is the first listed.
NCT02303678 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02303678 about?
NCT02303678 is a clinical study titled "D2C7 for Adult Patients With Recurrent Malignant Glioma". This is a Phase I study to determine the maximum tolerated dose (MTD) and/or recommended phase II dose of D2C7-IT (D2C7 Immunotoxin) when delivered intratumorally by convection-enhanced delivery (CED) to recurrent World Health Organization (WHO) grade III and IV malignant glioma patients, and/or to ...
What is the current status of trial NCT02303678?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2015-05-05. Estimated completion is 2024-03-25.
What interventions are being tested in trial NCT02303678?
The interventions under investigation include: D2C7-IT (DRUG).
Who is sponsoring clinical trial NCT02303678?
This trial is sponsored by Darell Bigner, which has 6 total clinical trials registered on ClinicalTrials.gov.
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