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NCT01645930 · OUTCOME

Cmax: Maximum Observed Plasma Concentration for Ixazomib

Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2018-11-08

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose

Analysis population: PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters.

Groups in this outcome

Ixazomib+Lenalidomide+Dexamethasone

Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 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
Ixazomib+Lenalidomide+Dexamethasone24

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone57.5738.507Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.507
        value
        57.57
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
    id
    OG000
    title
    Ixazomib+Lenalidomide+Dexamethasone
param Type
MEAN
population Description
PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters.
reporting Status
POSTED
time Frame
Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose
title
Cmax: Maximum Observed Plasma Concentration for Ixazomib
type
PRIMARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice