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NCT01478178 · ClinicalTrials.gov registry record · Phase 1
Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma
A Phase 1 study, sponsored by Kintara Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01478178: Completed Phase 1 study, sponsored by Kintara Therapeutics.
NCT01478178 is a Phase 1 study that has completed, run by Kintara Therapeutics. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01478178, a Phase 1 study, has completed, sponsored by Kintara Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.
Primary Outcome
The determination of MTD will be based on analysis of tolerance data from the first cycle of therapy in each dose group.
Interventions
- DRUG VAL-083 (Dianhydrogalactitol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT01478178 record still lists
NCT01478178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which VAL-083 (Dianhydrogalactitol) is the first listed.
NCT01478178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01478178 about?
NCT01478178 is a clinical study titled "Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma". The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.
What is the current status of trial NCT01478178?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2011-10. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01478178?
The interventions under investigation include: VAL-083 (Dianhydrogalactitol) (DRUG).
Who is sponsoring clinical trial NCT01478178?
This trial is sponsored by Kintara Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01478178's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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