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NCT03250299 · ClinicalTrials.gov registry record · Phase 1
Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
A Phase 1 study, sponsored by Basilea Pharmaceutica.
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03250299: Clinical Trial Phase 1 study, sponsored by Basilea Pharmaceutica.
NCT03250299 is a Phase 1 study that was terminated before completion, run by Basilea Pharmaceutica. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03250299, a Phase 1 study, was terminated before completion, sponsored by Basilea Pharmaceutica.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase (MGMT) promoter unmethylated glioblastoma (GBM). Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work in different ways to stop the growth of tumor cells, either by killing the cells, stopping them from dividing, or stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted agent BAL101553 and radiation therapy may work better in treating patients with GBM.
Primary Outcome
A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to BAL101553 or the combination of BAL101553 and radiation.
Interventions
- RADIATION Radiation Therapy
- DRUG Microtubule-Targeted Agent BAL101553
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2022-08-24 |
| Phase | Phase 1 |
Why NCT03250299 stopped before completion
NCT03250299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT03250299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03250299 about?
NCT03250299 is a clinical study titled "Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma". This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase (MGMT) promoter unmethylated glioblastoma (GBM). Drugs used in chemothera...
What is the current status of trial NCT03250299?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-12-15. Estimated completion is 2022-08-24.
What interventions are being tested in trial NCT03250299?
The interventions under investigation include: Radiation Therapy (RADIATION), Microtubule-Targeted Agent BAL101553 (DRUG).
Who is sponsoring clinical trial NCT03250299?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03250299's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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