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NCT01967758 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Safety and Immunogenicity of ADU-623
A Phase 1 study, sponsored by Providence Health & Services.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01967758: Completed Phase 1 study, sponsored by Providence Health & Services.
NCT01967758 is a Phase 1 study that has completed, run by Providence Health & Services. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01967758, a Phase 1 study, has completed, sponsored by Providence Health & Services.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a study for patients with brain tumors called astrocytic tumors. The study will enroll patients who have received standard treatment. The study will test a vaccine called ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if ADU-623 can be given safely to brain cancer patients and what is the better dose to give patients among the three doses that planned to be tested. This study will also evaluate the length of time before patients' cancer worsens and if ADU-623 helps patients to live longer. The study will also measure the body's immune system response to ADU-623.
Primary Outcome
The primary objective of this trial is to determine the maximum tolerated dose (MTD)(up to a dose of 1x10\^9 cfu IV) and characterize the safety profile of ADU-623 vaccine in patients with recurrent WHO Grade III/IV Astrocytomas. The MTD will be defined as the highest dose at which none or one out of 6 patients experiences a dose-limiting toxicity (DLT) that is possibly or probably related to the vaccine.
Interventions
- DRUG Antibiotics
- BIOLOGICAL Cohort 1
- BIOLOGICAL Cohort 3
- BIOLOGICAL Cohort 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-01-08 |
| Est. Completion | 2018-08-15 |
| Phase | Phase 1 |
What the finished NCT01967758 record still lists
NCT01967758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which Antibiotics is the first listed.
NCT01967758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01967758 about?
NCT01967758 is a clinical study titled "Phase I Study of Safety and Immunogenicity of ADU-623". This is a study for patients with brain tumors called astrocytic tumors. The study will enroll patients who have received standard treatment. The study will test a vaccine called ADU-623. ADU-623 has not been tested in humans before, so the goal of this study is to see if ADU-623 can be given safely...
What is the current status of trial NCT01967758?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2014-01-08. Estimated completion is 2018-08-15.
What interventions are being tested in trial NCT01967758?
The interventions under investigation include: Antibiotics (DRUG), Cohort 1 (BIOLOGICAL), Cohort 3 (BIOLOGICAL), Cohort 2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01967758?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01967758's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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