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NCT01897571 · ClinicalTrials.gov registry record · Phase 1
Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL
A Phase 1 study, sponsored by Epizyme.
- Completed
- Registry status
- Phase 1
- Development phase
- 400
- Enrollment target
NCT01897571: Completed Phase 1 study, sponsored by Epizyme.
NCT01897571 is a Phase 1 study that has completed, run by Epizyme. The registered enrollment target is 400 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (567% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01897571, a Phase 1 study, has completed, sponsored by Epizyme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 400 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).
Primary Outcome
Recommended Phase 2 dose (RP2D) of tazemetostat as administered orally twice daily (BID), continuously in 28-day cycles in subjects with advanced solid tumors or with relapsed and/or refractory B cell lymphomas as determined by incidence, seriousness, toxicity grade, and relatedness of treatment emergent dose limiting toxicities
Interventions
- DRUG Prednisolone
- DRUG Tazemetostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2013-06-13 |
| Est. Completion | 2021-11-02 |
| Phase | Phase 1 |
What the finished NCT01897571 record still lists
NCT01897571 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (567% higher).
The record links to 0 conditions, and to 2 interventions - of which Prednisolone is the first listed.
NCT01897571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01897571 about?
NCT01897571 is a clinical study titled "Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL". This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).
What is the current status of trial NCT01897571?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 400 participants. The study started on 2013-06-13. Estimated completion is 2021-11-02.
What interventions are being tested in trial NCT01897571?
The interventions under investigation include: Prednisolone (DRUG), Tazemetostat (DRUG).
Who is sponsoring clinical trial NCT01897571?
This trial is sponsored by Epizyme, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01897571's enrollment target sits among peer trials
400 75th of 2000 higher than 1,924 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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