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NCT01059643 · OUTCOME

Change in Tumor Size at Smallest Size (Best Response)

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
MEAN
Unit
percentage of change
Interval / dispersion
Standard Deviation
Time frame
Baseline until cycle with maximum change from baseline up to 36 weeks

What was measured

The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.

Analysis population: All enrolled participants who received at least 1 dose of study drug with results at baseline and at time of best response.

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
LY252335573

Reported measurements

Colorectal Cancer

Analysis denominator · Participants

GroupSource count
LY252335516
Values in percentage of change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
LY252335515.417.12Not reportedNot reportedNot reported
Gastroesophageal Cancer

Analysis denominator · Participants

GroupSource count
LY252335510
Values in percentage of change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
LY252335529.070.00Not reportedNot reportedNot reported
Non-Small Cell Lung Cancer

Analysis denominator · Participants

GroupSource count
LY252335523
Values in percentage of change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
LY252335521.948.69Not reportedNot reportedNot reported
Ovarian Cancer

Analysis denominator · Participants

GroupSource count
LY252335511
Values in percentage of change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
LY252335522.131.40Not reportedNot reportedNot reported
Prostate Cancer

Analysis denominator · Participants

GroupSource count
LY25233555
Values in percentage of change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
LY252335512.215.91Not reportedNot reportedNot reported
Squamous Cell Carcinoma of Head and Neck

Analysis denominator · Participants

GroupSource count
LY25233558
Values in percentage of change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
LY25233553.930.67Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.12
        value
        15.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Colorectal Cancer
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.00
        value
        29.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Gastroesophageal Cancer
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.69
        value
        21.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Non-Small Cell Lung Cancer
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.40
        value
        22.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Ovarian Cancer
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.91
        value
        12.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Prostate Cancer
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.67
        value
        3.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Squamous Cell Carcinoma of Head and Neck
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    units
    Participants
description
The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.
dispersion Type
Standard Deviation
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
MEAN
population Description
All enrolled participants who received at least 1 dose of study drug with results at baseline and at time of best response.
reporting Status
POSTED
time Frame
Baseline until cycle with maximum change from baseline up to 36 weeks
title
Change in Tumor Size at Smallest Size (Best Response)
type
SECONDARY
unit Of Measure
percentage of change

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

Preserved source evidence · Not medical advice