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NCT03028103 · ClinicalTrials.gov registry record · Phase 1
Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients
A Phase 1 study, sponsored by Epizyme.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03028103: Completed Phase 1 study, sponsored by Epizyme.
NCT03028103 is a Phase 1 study that has completed, run by Epizyme. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03028103, a Phase 1 study, has completed, sponsored by Epizyme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID continuously in 28-day cycles in both study parts.
Interventions
- DRUG Fluconazole
- DRUG Omeprazole
- DRUG Tazemetostat
- DRUG Repaglinide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-03-27 |
| Est. Completion | 2019-11-29 |
| Phase | Phase 1 |
What the finished NCT03028103 record still lists
NCT03028103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Fluconazole is the first listed.
NCT03028103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03028103 about?
NCT03028103 is a clinical study titled "Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients". This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID continuously in 28-day cycles in both study parts.
What is the current status of trial NCT03028103?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-03-27. Estimated completion is 2019-11-29.
What interventions are being tested in trial NCT03028103?
The interventions under investigation include: Fluconazole (DRUG), Omeprazole (DRUG), Tazemetostat (DRUG), Repaglinide (DRUG).
Who is sponsoring clinical trial NCT03028103?
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 NCT03028103's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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