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NCT01634685 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01634685: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT01634685 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01634685, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a phase I study incorporating bavituximab into the care of patients with rectal adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no reference therapy as we are trying to identify the MTD of bavituximab in this combination.
Primary Outcome
To determine dose-limiting toxicities (DLT) for bavituximab when administered on a weekly basis concurrently with external beam radiation therapy.
Interventions
- DRUG Capecitabine
- RADIATION Radiation
- DRUG Bavituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-08-08 |
| Est. Completion | 2017-10-06 |
| Phase | Phase 1 |
What the finished NCT01634685 record still lists
NCT01634685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT01634685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01634685 about?
NCT01634685 is a clinical study titled "A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma". This is a phase I study incorporating bavituximab into the care of patients with rectal adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no reference therapy as we are trying to identify the MTD of bavituximab in this combination.
What is the current status of trial NCT01634685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2012-08-08. Estimated completion is 2017-10-06.
What interventions are being tested in trial NCT01634685?
The interventions under investigation include: Capecitabine (DRUG), Radiation (RADIATION), Bavituximab (DRUG).
Who is sponsoring clinical trial NCT01634685?
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 NCT01634685's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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