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NCT01728805 · ClinicalTrials.gov registry record · Phase 3
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
A Phase 3 study, sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 3
- Development phase
- 372
- Enrollment target
NCT01728805: Completed Phase 3 study, sponsored by Kyowa Kirin.
NCT01728805 is a Phase 3 study that has completed, run by Kyowa Kirin. The registered enrollment target is 372 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01728805, a Phase 3 study, has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 372 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
Primary Outcome
Progression was defined as follows, based on Olsen (2011): * Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node \> 1.5 cm in the long axis or \> 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or \> 50% increase from nadir in SPD of lymph nodes in those with PR * Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin sco
Interventions
- DRUG Vorinostat
- BIOLOGICAL KW-0761
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2012-11 |
| Est. Completion | 2021-02-17 |
| Phase | Phase 3 |
What the finished NCT01728805 record still lists
NCT01728805 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Vorinostat is the first listed.
NCT01728805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01728805 about?
NCT01728805 is a clinical study titled "Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL". The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
What is the current status of trial NCT01728805?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 372 participants. The study started on 2012-11. Estimated completion is 2021-02-17.
What interventions are being tested in trial NCT01728805?
The interventions under investigation include: Vorinostat (DRUG), KW-0761 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01728805?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01728805's enrollment target sits among peer trials
372 991st of 2000 higher than 1,009 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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