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NCT01112293 · OUTCOME

Time to Progression and Overall Survival

Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma · Source last updated 2020-04-10

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
18 months

What was measured

Assessment of time to disease progression and overall survival

Analysis population: Outcome analysis presented in manuscript of results of trial based on 13 participants.

Groups in this outcome

Investigational Drug infusion-for Safety and Effectiveness

Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.

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

Analysis denominator · Participants

GroupSource count
Investigational Drug infusion-for Safety and Effectiveness13

Reported measurements

Time to Progression
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Investigational Drug infusion-for Safety and Effectiveness1.4Not reported1.2NAData was reported as a one sided Confidence Interval, so there is no upper limit interval reported
Overall Survival
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Investigational Drug infusion-for Safety and Effectiveness12Not reported7.1714.43Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data was reported as a one sided Confidence Interval, so there is no upper limit interval reported
        group Id
        OG000
        lower Limit
        1.2
        upper Limit
        NA
        value
        1.4
    title
    Time to Progression
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.17
        upper Limit
        14.43
        value
        12
    title
    Overall Survival
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Assessment of time to disease progression and overall survival
dispersion Type
95% Confidence Interval
groups
  1. description
    Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
    id
    OG000
    title
    Investigational Drug infusion-for Safety and Effectiveness
param Type
MEDIAN
population Description
Outcome analysis presented in manuscript of results of trial based on 13 participants.
reporting Status
POSTED
time Frame
18 months
title
Time to Progression and Overall Survival
type
OTHER_PRE_SPECIFIED
unit Of Measure
Months

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

Preserved source evidence · Not medical advice