An Open-Label, Multicentre, Phase 1/2 Study of E7438 (EZH2 Histone Methyl Transferase [HMT] Inhibitor) as a Single Agent in Subjects With Advanced Solid Tumours or With B-cell Lymphomas
This is a multicentre, open-label, Phase 1/2 study that is being conducted in two parts. The
Phase 1 portion (closed to accrual as of January 25, 2016) comprises dose escalation and
establishment of the recommended Phase 2 dose (RP2D) when EPZ-6438 (E7438) is given BID
(twice daily) orally on a continuous basis. Additionally, in separate cohorts in Phase 1,
the effect of food on the bioavailability of EPZ-6438 as well as the drug-drug interaction
(DDI) potential of EPZ-6438 are being evaluated. The Phase 2 part was initiated after
determining the RP2D. Phase 2 enrolls subjects with DLBCL and FL for the determination of
efficacy and safety of EPZ-6438 in 5 separate cohorts determined by centrally confirmed
histology, cell of origin (COO), and EZH2 mutation status.
View this trial on ClinicalTrials.gov
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