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NCT01897571 · OUTCOME

Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)

Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL · Source last updated 2024-03-26

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

Measure
NUMBER
Unit
mg BID
Interval / dispersion
Not reported
Time frame
The first 28-day cycle of therapy

What was measured

Recommended Phase 2 dose (RP2D) of tazemetostat as 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 as determined by incidence, seriousness, toxicity grade, and relatedness of treatment emergent dose limiting toxicities

Groups in this outcome

Phase 1

Patients in the Phase 1 portion of the study. Tazemetostat: Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 164

Reported measurements

Source class 1
Values in mg BID · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1800Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        800
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    units
    Participants
description
Recommended Phase 2 dose (RP2D) of tazemetostat as 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 as determined by incidence, seriousness, toxicity grade, and relatedness of treatment emergent dose limiting toxicities
groups
  1. description
    Patients in the Phase 1 portion of the study. Tazemetostat: Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.
    id
    OG000
    title
    Phase 1
param Type
NUMBER
reporting Status
POSTED
time Frame
The first 28-day cycle of therapy
title
Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)
type
PRIMARY
unit Of Measure
mg BID

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice