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NCT03452930 · ClinicalTrials.gov registry record · Phase 1
Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT03452930: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03452930 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03452930, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of tinostamustine (EDO-S101) given with or without radiation therapy in treating patients with newly diagnosed MGMT-unmethylated glioblastoma. Tinostamustine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in patients with glioblastoma.
Primary Outcome
Defined by dose limiting toxicity (DLT). Toxicity will be evaluated according to the most current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) toxicity criteria. The MTD is confirmed when six (6) patients are treated at a dose level with less than two (2) DLTs.
Interventions
- RADIATION Radiation Therapy
- DRUG Tinostamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2024-06-05 |
| Phase | Phase 1 |
What the finished NCT03452930 record still lists
NCT03452930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT03452930 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03452930 about?
NCT03452930 is a clinical study titled "Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastoma". This phase I trial studies the side effects and best dose of tinostamustine (EDO-S101) given with or without radiation therapy in treating patients with newly diagnosed MGMT-unmethylated glioblastoma. Tinostamustine may stop the growth of tumor cells by blocking some of the enzymes needed for cell g...
What is the current status of trial NCT03452930?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2018-08-13. Estimated completion is 2024-06-05.
What interventions are being tested in trial NCT03452930?
The interventions under investigation include: Radiation Therapy (RADIATION), Tinostamustine (DRUG).
Who is sponsoring clinical trial NCT03452930?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03452930's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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