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NCT02145403 · OUTCOME

Phase I: Maximum Tolerated Dose (MTD) of Carfilzomib

Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies · Source last updated 2022-01-03

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

Measure
NUMBER
Unit
milligrams per square meter (mg/m^2)
Interval / dispersion
Not reported
Time frame
Up to day 28

What was measured

Subjects were enrolled on the first dose level (20 mg/m\^2), following a standard 3+3 dose escalation. For any given dose level, if none of the 3 subjects developed a treatment-related dose limiting toxicity (DLT), defined per protocol, dose escalation would follow. If a DLT occurred in any given dose level, the cohort would be expanded to 6. Further dose escalation would be made only if DLTs occurred in \<2 out of 6 subjects. If \>=2 of 6 develop DLTs, dose de-escalation would be made to the previous level. The highest dose level at which no more than one of six participants experience a DLT defines the MTD.

Analysis population: Phase 1 study participants

Groups in this outcome

Phase 1 Study Participants

Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Dose Level 1, 2, 3, 4: Participants were administered 20, 27, 36, or 45 mg/m\^2 of Carfilzomib on days +6 and +7, respectively. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.

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 1 Study Participants14

Reported measurements

Source class 1
Values in milligrams per square meter (mg/m^2) · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1 Study Participants36Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        36
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Subjects were enrolled on the first dose level (20 mg/m\^2), following a standard 3+3 dose escalation. For any given dose level, if none of the 3 subjects developed a treatment-related dose limiting toxicity (DLT), defined per protocol, dose escalation would follow. If a DLT occurred in any given dose level, the cohort would be expanded to 6. Further dose escalation would be made only if DLTs occurred in \<2 out of 6 subjects. If \>=2 of 6 develop DLTs, dose de-escalation would be made to the previous level. The highest dose level at which no more than one of six participants experience a DLT defines the MTD.
groups
  1. description
    Participants in all cohorts were administered 20 mg/m\^2 of Carfilzomib on days +1 and +2, via intravenous catheter (IV) over 30 minutes. Dose Level 1, 2, 3, 4: Participants were administered 20, 27, 36, or 45 mg/m\^2 of Carfilzomib on days +6 and +7, respectively. Participants in all cohorts were administered tacrolimus at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
    id
    OG000
    title
    Phase 1 Study Participants
param Type
NUMBER
population Description
Phase 1 study participants
reporting Status
POSTED
time Frame
Up to day 28
title
Phase I: Maximum Tolerated Dose (MTD) of Carfilzomib
type
PRIMARY
unit Of Measure
milligrams per square meter (mg/m^2)

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

Preserved source evidence · Not medical advice