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NCT03896568 · ClinicalTrials.gov registry record · Phase 1
MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
A Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT03896568: Recruiting Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, sponsored by M.D. Anderson Cancer Center.
NCT03896568 is a Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 36 participants, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03896568, a Phase 1 study of Recurrent Glioblastoma and Recurrent Malignant Glioma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.
Primary Outcome
The MTD will be defined as the dose below the dose that results in greater than or equal to one-third of the subjects exposed who experienced grade 3 or 4 (except hematological, grade 4 required) toxicity according to National Cancer Institute Common Toxicity Criteria that is deemed to be at least "probably related" to the study drug (i.e., dose-limiting toxicity \[DLT\]).
Conditions Studied
Interventions
- PROCEDURE Therapeutic Conventional Surgery
- BIOLOGICAL Oncolytic Adenovirus Ad5-DNX-2401
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
What NCT03896568 shows while recruiting
NCT03896568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (47% lower).
The record links to 5 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Therapeutic Conventional Surgery is the first listed.
NCT03896568 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03896568 about?
NCT03896568 is a clinical study titled "MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma". This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause ...
What is the current status of trial NCT03896568?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2019-02-12. Estimated completion is 2027-09-30.
What conditions does trial NCT03896568 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma, Recurrent Malignant Glioma, Recurrent Gliosarcoma, Recurrent Anaplastic Astrocytoma, IDH1 wt Allele.
What interventions are being tested in trial NCT03896568?
The interventions under investigation include: Therapeutic Conventional Surgery (PROCEDURE), Oncolytic Adenovirus Ad5-DNX-2401 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03896568?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03896568 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03896568's enrollment target sits among peer trials
36 27th of 62 higher than 34 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma 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.
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