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NCT01397708 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma
A Phase 1 study of Melanoma, sponsored by Alaunos Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 9
- Study locations
NCT01397708: Completed Phase 1 study of Melanoma, sponsored by Alaunos Therapeutics.
NCT01397708 is a Phase 1 study of Melanoma that has completed, run by Alaunos Therapeutics. The registered enrollment target is 26 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397708, a Phase 1 study of Melanoma, has completed, sponsored by Alaunos Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 9
- Study locations
Study Summary
This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may 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 tumor injections of INXN-2001 given in combination with different doses of INXN-1001.
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 INXN-2001
- DRUG INXN-1001
Study Locations (9)
California
- The Angeles Clinic - Los Angeles
Illinois
- Oncology Specialists - Park Ridge
Indiana
- Indiana University Health Goshen Center for Cancer Care - Goshen
Kentucky
- James Graham Brown Cancer Center - Louisville
Missouri
- Washington University - St Louis
New Jersey
- Atlantic Melanoma Center - Morristown
Pennsylvania
- St. Lukes - Easton
Texas
- Mary Crowley Cancer Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT01397708 record still lists
NCT01397708 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 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which INXN-2001 is the first listed.
NCT01397708 lists 9 locations in 9 states (California, Illinois, Indiana).
Frequently Asked Questions
What is clinical trial NCT01397708 about?
NCT01397708 is a clinical study titled "Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma". This research study involves two investigational drugs, an Activator Ligand (INXN-1001) in combination with an Adenovirus Vector Engineered to Express hIL-12 (INXN-2001). IL-12 is a protein that may improve the body's natural response to disease by enhancing the ability of the immune system to kill ...
What is the current status of trial NCT01397708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2011-08. Estimated completion is 2014-09.
What conditions does trial NCT01397708 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01397708?
The interventions under investigation include: INXN-2001 (BIOLOGICAL), INXN-1001 (DRUG).
Who is sponsoring clinical trial NCT01397708?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01397708 being conducted?
This trial has 9 study locations across California, Illinois, Indiana, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01397708's enrollment target sits among peer trials
26 211th of 266 higher than 53 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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