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NCT00274651 · OUTCOME

Duration of Response

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas · Source last updated 2015-07-28

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
throughout the study, or for a maximum of 2 years

What was measured

Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.

Analysis population: Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days

Groups in this outcome

Arm A (CTCL, ITT Population)

CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV

Arm B (PTCL, ITT Population)

PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV

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

Analysis denominator · Participants

GroupSource count
Arm A (CTCL, ITT Population)2
Arm B (PTCL, ITT Population)4

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm A (CTCL, ITT Population)83Not reported56129Not reported
Arm B (PTCL, ITT Population)109Not reported7460Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56
        upper Limit
        129
        value
        83
      2. group Id
        OG001
        lower Limit
        7
        upper Limit
        460
        value
        109
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.
dispersion Type
Full Range
groups
  1. description
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    OG000
    title
    Arm A (CTCL, ITT Population)
  2. description
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    OG001
    title
    Arm B (PTCL, ITT Population)
param Type
MEDIAN
population Description
Duration of response (ITT population) was estimated by Kaplan-Meier method for CTCL/PTCL arms. 2 CTCL and 2 PTCL patients did not progress and were censored. Median duration of response and full range (days) are presented for 2 patients with CTCL and 4 patients with PTCL. The 2 CTCL patients being evaluable had response durations of 56 and 129 days
reporting Status
POSTED
time Frame
throughout the study, or for a maximum of 2 years
title
Duration of Response
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice