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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: Completed Phase 1 study, sponsored by Darell Bigner.
NCT02303678 is a Phase 1 study that has completed, run by Darell Bigner. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MTD is the dose that results in an estimated DLT rate based upon the CRM model that is nearest to the target DLT rate of 0.25. DLTs include any ≥ Gr.3 non-hematologic toxicities, any ≥ Gr.3 neurological toxicities, and any ≥ Gr.3 hematologic toxicities that do not resolve to pre-treatment baseline or ≤ Gr.1 within 2 weeks or any toxicity that resolves within the 2 week period, but then recurs during that same 2 week period. Adverse events will be collected using Common Terminology Criteria f
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 |
What the finished NCT02303678 record still lists
NCT02303678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which D2C7-IT is the first listed.
NCT02303678 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02303678's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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