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NCT00932698 · OUTCOME

Recommended Phase 2 Dose (RP2D) of Ixazomib

Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma · Source last updated 2019-08-07

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

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
Cycle 1 through Cycle 39 (Up to 28.3 months)

What was measured

The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond.

Analysis population: Safety population included all participants who received at least 1 dose of ixazomib.

Groups in this outcome

Ixazomib (All Groups)

All participants who received ixazomib 0.24 mg/m\^2, 0.48 mg/m\^2, 0.8 mg/m\^2, 1.2 mg/m\^2, 1.68 mg/m\^2, 2 mg/m\^2 or 2.23 mg/m\^2 in dose-escalation cohorts.

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

Analysis denominator · Participants

GroupSource count
Ixazomib (All Groups)26

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib (All Groups)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond.
groups
  1. description
    All participants who received ixazomib 0.24 mg/m\^2, 0.48 mg/m\^2, 0.8 mg/m\^2, 1.2 mg/m\^2, 1.68 mg/m\^2, 2 mg/m\^2 or 2.23 mg/m\^2 in dose-escalation cohorts.
    id
    OG000
    title
    Ixazomib (All Groups)
param Type
NUMBER
population Description
Safety population included all participants who received at least 1 dose of ixazomib.
reporting Status
POSTED
time Frame
Cycle 1 through Cycle 39 (Up to 28.3 months)
title
Recommended Phase 2 Dose (RP2D) of Ixazomib
type
PRIMARY
unit Of Measure
mg/m^2

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice