At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at consent
- ✓ECOG performance status 0, 1, or 2
- ✓Relapsed/refractory B-cell lymphoma (DLBCL, PMBCL, MZL, MCL) after ≥2 lines of prior standard therapy including alkylator/anthracycline/anti-CD20, unable to benefit from ASCT
- ✓Relapsed/refractory follicular lymphoma (all grades) after ≥2 lines of systemic therapy including ≥1 anti-CD20 regimen and alkylating agents, no curative option or contraindication to available therapies
- ✕Pregnant or nursing
- ✕Active CNS or leptomeningeal metastasis
- ✕Prior malignancy (except disease-free ≥3 years, non-melanoma skin cancer, or treated in situ carcinoma)
- ✕Grade ≥3 thrombocytopenia, neutropenia, or anemia; any history of myeloid malignancies including MDS
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize the Effects of a Moderate CYP3A Inhibitor on the Pharmacokinetics of Tazemetostat (EPZ-6438) (Part A), the Effects of Tazemetostat on the Pharmacokinetics of CYP2C8 and CYP2C19 Substrates, and the Effect of Increased Gastric pH on the Pharmacokinetics of Tazemetostat (Part B) in Subjects With B-cell Lymphoma or Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Tazemetostat, Fluconazole, and 2 other interventions for Diffuse Large B Cell Lymphoma and 4 related conditions. Completed, enrolled 32 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Tazemetostat is a selective oral small molecule inhibitor of EZH2
200mg will be orally administered QD for 4 days in order to determine CYP3A4 inhibition when administered concomitantly with tazemetostat
Using omeprazole as a probe substrate, 20mg will be orally administered for a total of 5 days in order to determine the potential of tazemetostat to inhibit or induce CYP2C19. Omeprazole is also being used to determine the effect of increased gastric pH on metabolism of tazemetostat.
Using repaglinide as a probe substrate, 25mg will be orally administered for a total of 2 days in order to determine the potential of tazemetostat to inhibit or induce CYP2C8.