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NCT02026271 · ClinicalTrials.gov registry record · Phase 1
A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Glioblastoma or Malignant Glioma
A Phase 1 study of Glioblastoma Multiforme and Anaplastic Oligoastrocytoma, sponsored by Alaunos Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 6
- Study locations
NCT02026271: Completed Phase 1 study of Glioblastoma Multiforme and Anaplastic Oligoastrocytoma, sponsored by Alaunos Therapeutics.
NCT02026271 is a Phase 1 study of Glioblastoma Multiforme and Anaplastic Oligoastrocytoma that has completed, run by Alaunos Therapeutics. The registered enrollment target is 40 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (58% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02026271, a Phase 1 study of Glioblastoma Multiforme and Anaplastic Oligoastrocytoma, has completed, sponsored by Alaunos Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 6
- Study locations
Study Summary
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor. The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of Ad-RTS-hIL-12 given with oral veledimex.
Primary Outcome
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs). Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
Conditions Studied
Interventions
- BIOLOGICAL Ad-RTS-hIL-12
- DRUG veledimex
Study Locations (6)
California
- Cedars-Sinai - Los Angeles
- University of California - San Francisco - San Francisco
Illinois
- Northwestern - Chicago
- University of Chicago - Chicago
Massachusetts
- Brigham & Women's - Boston
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-06 |
| Est. Completion | 2019-08 |
| Phase | Phase 1 |
What the finished NCT02026271 record still lists
NCT02026271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Ad-RTS-hIL-12 is the first listed.
NCT02026271 lists 6 locations in 4 states (California, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT02026271 about?
NCT02026271 is a clinical study titled "A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Glioblastoma or Malignant Glioma". This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to...
What is the current status of trial NCT02026271?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2015-06. Estimated completion is 2019-08.
What conditions does trial NCT02026271 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Anaplastic Oligoastrocytoma.
What interventions are being tested in trial NCT02026271?
The interventions under investigation include: Ad-RTS-hIL-12 (BIOLOGICAL), veledimex (DRUG).
Who is sponsoring clinical trial NCT02026271?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02026271 being conducted?
This trial has 6 study locations across California, Illinois, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02026271's enrollment target sits among peer trials
40 46th of 88 higher than 41 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme 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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