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NCT01059643 · OUTCOME

Tumor Marker Values as Relevant to Specific Tumor Types at Baseline

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline

What was measured

The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).

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

CRC-BRAF Mutation, Negative

Analysis denominator · Participants

GroupSource count
LY252335517
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233552Not reportedNot reportedNot reportedNot reported
CRC-BRAF Mutation, Not Done/Unknown

Analysis denominator · Participants

GroupSource count
LY252335517
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY252335515Not reportedNot reportedNot reportedNot reported
CRC-KRAS Mutation, Positive

Analysis denominator · Participants

GroupSource count
LY252335517
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233559Not reportedNot reportedNot reportedNot reported
CRC-KRAS Mutation, Negative

Analysis denominator · Participants

GroupSource count
LY252335517
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233557Not reportedNot reportedNot reportedNot reported
CRC-KRAS Mutation, Not Done

Analysis denominator · Participants

GroupSource count
LY252335517
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233551Not reportedNot reportedNot reportedNot reported
GE-KRAS Mutation, Negative

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233551Not reportedNot reportedNot reportedNot reported
GE-KRAS Mutation, Not Done/Unknown

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY252335512Not reportedNot reportedNot reportedNot reported
NSCLC-KRAS Mutation, Positive

Analysis denominator · Participants

GroupSource count
LY252335529
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233553Not reportedNot reportedNot reportedNot reported
NSCLC-KRAS Mutation, Negative

Analysis denominator · Participants

GroupSource count
LY252335529
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233555Not reportedNot reportedNot reportedNot reported
NSCLC-KRAS Mutation, Not Done/Unknown

Analysis denominator · Participants

GroupSource count
LY252335529
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY252335521Not reportedNot reportedNot reportedNot reported
Ovarian-BRCA1 Mutation, Negative

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233553Not reportedNot reportedNot reportedNot reported
Ovarian-BRCA1 Mutation, Not Done/Unknown

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY252335510Not reportedNot reportedNot reportedNot reported
Ovarian-BRCA2 Mutation, Negative

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233553Not reportedNot reportedNot reportedNot reported
Ovarian-BRCA2 Mutation, Not Done/Unknown

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY252335510Not reportedNot reportedNot reportedNot reported
SCCHN-APC Mutation, Negative

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233551Not reportedNot reportedNot reportedNot reported
SCCHN-APC Mutation, Not Done/Unknown

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY252335512Not reportedNot reportedNot reportedNot reported
SCCHN-HPV (HPV-31 Positive) Mutation

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY25233551Not reportedNot reportedNot reportedNot reported
SCCHN-HPV Mutation, Not Done/Unknown

Analysis denominator · Participants

GroupSource count
LY252335513
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY252335512Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    CRC-BRAF Mutation, Negative
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    CRC-BRAF Mutation, Not Done/Unknown
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    CRC-KRAS Mutation, Positive
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    CRC-KRAS Mutation, Negative
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    CRC-KRAS Mutation, Not Done
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    GE-KRAS Mutation, Negative
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    GE-KRAS Mutation, Not Done/Unknown
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    NSCLC-KRAS Mutation, Positive
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    NSCLC-KRAS Mutation, Negative
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    NSCLC-KRAS Mutation, Not Done/Unknown
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Ovarian-BRCA1 Mutation, Negative
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Ovarian-BRCA1 Mutation, Not Done/Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      103
    units
    Participants
description
The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).
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
COUNT_OF_PARTICIPANTS
population Description
All enrolled participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Baseline
title
Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice