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NCT02356159 · OUTCOME

Phase I: Maximum Tolerated Dose (MTD) of Palifermin

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation · Source last updated 2025-09-30

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

Measure
NUMBER
Unit
mcg/kg
Interval / dispersion
Not reported
Time frame
Approximately 30-day post-transplant

What was measured

MTD is defined as the dose level at which no more than 1 (of ≤ 6) participants who experience dose-limiting toxicity (DLT), and the dose below that at which at least 2 (of ≤ 6) participants have a DLT as a result of the drug. A DLT is non-relapse mortality before day 30 post transplantation regardless of attribution to palifermin. and non-hematologic grade 4 (life-threatening) adverse events within 14 days after treatment with palifermin possibly related to drug.

Analysis population: All participants = (total # for phase 1).

Groups in this outcome

All Phase I Participants

All participants who received at least one dose of palifermin.

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

Analysis denominator · Participants

GroupSource count
All Phase I Participants15

Reported measurements

Source class 1
Values in mcg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Phase I Participants720Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        720
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
MTD is defined as the dose level at which no more than 1 (of ≤ 6) participants who experience dose-limiting toxicity (DLT), and the dose below that at which at least 2 (of ≤ 6) participants have a DLT as a result of the drug. A DLT is non-relapse mortality before day 30 post transplantation regardless of attribution to palifermin. and non-hematologic grade 4 (life-threatening) adverse events within 14 days after treatment with palifermin possibly related to drug.
groups
  1. description
    All participants who received at least one dose of palifermin.
    id
    OG000
    title
    All Phase I Participants
param Type
NUMBER
population Description
All participants = (total # for phase 1).
reporting Status
POSTED
time Frame
Approximately 30-day post-transplant
title
Phase I: Maximum Tolerated Dose (MTD) of Palifermin
type
PRIMARY
unit Of Measure
mcg/kg

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

Preserved source evidence · Not medical advice