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NCT01773889 · ClinicalTrials.gov registry record · Phase 2
A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer
A Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01773889: Clinical Trial Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01773889 is a Phase 2 study that was terminated before completion, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01773889, a Phase 2 study, was terminated before completion, sponsored by The University of Texas Health Science Center at San Antonio.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial ovarian cancers, enhancing treatment efficacy.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR. Failure to respond criteria are not based on RECIST criteria, which have unclear application to immune-based clinical trials. Instead, novel lack-of-failure criteria, rather than failure-of-success criteria have b
Interventions
- DRUG Denileukin Diftitox/SC Pegylated IFNα-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
Why NCT01773889 stopped before completion
NCT01773889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Denileukin Diftitox/SC Pegylated IFNα-2a is the first listed.
NCT01773889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01773889 about?
NCT01773889 is a clinical study titled "A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer". This study will test the hypothesis that adding pegylated IFN (IFN)a-2b to denileukin diftitox improves the potential of denileukin diftitox alone to deplete regulatory T cells (Tregs) and will thereby boost tumor immunity in patients with advanced-stage epithelial ovarian cancers, enhancing treatme...
What is the current status of trial NCT01773889?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2009-06. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01773889?
The interventions under investigation include: Denileukin Diftitox/SC Pegylated IFNα-2a (DRUG).
Who is sponsoring clinical trial NCT01773889?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01773889's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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