A Study on the Effect of Tazemetostat (study drug) in Patients with Advanced Solid Tumors or with B Cell Lymphomas

Update Il y a 4 ans
Reference: EUCTR2012-004083-21

Woman and Man

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Extract

Phase 1 To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of tazemetostat as a single agent 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 Phase 2 To determine the objective response rate (ORR; complete response + partial response [CR + PR]) of tazemetostat in subjects with enhancer of zeste homolog 2 (EZH2) gene mutation positive or negative (wild-type) with histologically confirmed diffuse large B cell lymphoma (DLBCL) or follicular lymphomas (FL), with relapsed or refractory disease.


Inclusion criteria

  • Relapsed or refractory Diffuse Large B Cell Lymphoma, Follicular
  • Lymphoma, Advanced solid tumor