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NCT01059643 · OUTCOME

Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Baseline until progressive disease up to 36 weeks post-baseline

What was measured

Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.

Analysis population: All enrolled participants who received at least 1 dose of study drug.

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 percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY252335537.5Not reported17.860.9Not reported
Gastroesophageal Cancer

Analysis denominator · Participants

GroupSource count
LY252335513
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY252335516.7Not reported3.043.8Not reported
Non-Small Cell Lung Cancer

Analysis denominator · Participants

GroupSource count
LY252335529
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY252335538.5Not reported22.656.4Not reported
Ovarian Cancer

Analysis denominator · Participants

GroupSource count
LY252335513
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY252335530.8Not reported11.357.3Not reported
Prostate Cancer

Analysis denominator · Participants

GroupSource count
LY252335518
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY252335547.1Not reported26.068.9Not reported
Squamous Cell Carcinoma of Head and Neck

Analysis denominator · Participants

GroupSource count
LY252335513
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LY252335550.0Not reported22.277.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.8
        upper Limit
        60.9
        value
        37.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Colorectal Cancer
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        43.8
        value
        16.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Gastroesophageal Cancer
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.6
        upper Limit
        56.4
        value
        38.5
    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
        11.3
        upper Limit
        57.3
        value
        30.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Ovarian Cancer
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.0
        upper Limit
        68.9
        value
        47.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      units
      Participants
    title
    Prostate Cancer
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.2
        upper Limit
        77.8
        value
        50.0
    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
Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.
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
NUMBER
population Description
All enrolled participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Baseline until progressive disease up to 36 weeks post-baseline
title
Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice