Participant flow

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma · Source last updated 2021-04-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status were to be treated and PK blood samples collected after a single tazemetostat 800 mg dose on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Subjects were to receive a single oral 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was orally administered at a dose of 800 mg twice daily.

   id

   FG000

   title

   Part 1 (Pharmacokinetics)

2. description

   subjects with BAP1-deficient relapsed or refractory malignant mesothelioma were to receive orally administered tazemetostat 800 mg twice daily starting on Cycle 1 Day 1.

   id

   FG001

   title

   Part 2 (Efficacy)

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         61

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         61

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Seventy-four subjects were enrolled and treated with study drug (13 subjects in Part 1 and 61 subjects in Part 2). No patients were excluded due to unmet study eligibility criteria.

recruitment Details

Study EZH-203 was conducted at 16 clinical sites in France, UK, and USA. Subjects were screened for eligibility within 21 days of the planned date of the first dose of tazemetostat. Eligible subjects were enrolled into 2 different parts: * Part 1 - Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status * Part 2 - Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma.

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Preserved source evidence · Not medical advice