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NCT01984255 · ClinicalTrials.gov registry record · Phase 1
A Two-arm, Single Center Phase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01984255: Clinical Trial Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT01984255 is a Phase 1 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01984255, a Phase 1 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a Open label, two-arm, randomized, two agent, single center trial.
Primary Outcome
Toxicities will be assessed via NCI's CTCAE v4.1 toxicity criteria. Dose limiting toxicities (DLTs) will be defined as drug-related grade 3-5 adverse events experienced within the first 12 weeks of study treatment. The maximal tolerated dose (MTD) will be exceeded if more than 30% of patients on the study experience DLTs.
Interventions
- DRUG Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV
- DRUG Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
Why NCT01984255 stopped before completion
NCT01984255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV is the first listed.
NCT01984255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01984255 about?
NCT01984255 is a clinical study titled "A Two-arm, Single Center Phase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients". This is a Open label, two-arm, randomized, two agent, single center trial.
What is the current status of trial NCT01984255?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01984255?
The interventions under investigation include: Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV (DRUG), Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. (DRUG).
Who is sponsoring clinical trial NCT01984255?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01984255's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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