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NCT01059643 · OUTCOME

Progression Free Survival (PFS)

A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck · Source last updated 2019-09-18

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

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment

What was measured

PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.

Analysis population: All enrolled participants who received at least 1 dose of study drug. Percentage (%) of participants censored were colorectal cancer 5.9%; gastroesophageal cancer 0.0%, non-small cell lung cancer 3.4%, ovarian cancer 15.4%, prostate cancer 16.7%, and squamous cell carcinoma of the head and neck 15.4%.

Groups in this outcome

LY2523355

LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.

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

Analysis denominator · Participants

GroupSource count
LY2523355103

Reported measurements

Colorectal Cancer

Analysis denominator · Participants

GroupSource count
LY252335517
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY25233551.30Not reported1.282.69Not reported
Gastroesophageal Cancer

Analysis denominator · Participants

GroupSource count
LY252335513
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY25233551.25Not reported0.621.51Not reported
Non-Small Cell Lung Cancer

Analysis denominator · Participants

GroupSource count
LY252335529
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY25233551.31Not reported1.281.91Not reported
Ovarian Cancer

Analysis denominator · Participants

GroupSource count
LY252335513
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY25233551.31Not reported1.182.10Not reported
Prostate Cancer

Analysis denominator · Participants

GroupSource count
LY252335518
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY25233552.30Not reported1.452.66Not reported
Squamous Cell Carcinoma of Head and Neck

Analysis denominator · Participants

GroupSource count
LY252335513
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY25233551.51Not reported0.722.76Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.28
        upper Limit
        2.69
        value
        1.30
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Colorectal Cancer
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.62
        upper Limit
        1.51
        value
        1.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Gastroesophageal Cancer
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.28
        upper Limit
        1.91
        value
        1.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    Non-Small Cell Lung Cancer
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.18
        upper Limit
        2.10
        value
        1.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Ovarian Cancer
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2.66
        value
        2.30
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      units
      Participants
    title
    Prostate Cancer
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        2.76
        value
        1.51
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Squamous Cell Carcinoma of Head and Neck
denoms
  1. counts
    1. group Id
      OG000
      value
      103
    units
    Participants
description
PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.
dispersion Type
90% Confidence Interval
groups
  1. description
    LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
    id
    OG000
    title
    LY2523355
param Type
MEDIAN
population Description
All enrolled participants who received at least 1 dose of study drug. Percentage (%) of participants censored were colorectal cancer 5.9%; gastroesophageal cancer 0.0%, non-small cell lung cancer 3.4%, ovarian cancer 15.4%, prostate cancer 16.7%, and squamous cell carcinoma of the head and neck 15.4%.
reporting Status
POSTED
time Frame
Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice