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NCT02014116 · OUTCOME

Number of Participants With Tumor Response

A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body · Source last updated 2019-12-27

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline through progressive disease (Up to 7.36 months)

What was measured

Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

Analysis population: All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.

Groups in this outcome

Cohort A

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle

Cohort B

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

Cohort C

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Cohort A1
Cohort B5
Cohort C10

Reported measurements

Complete Repsonse
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A0Not reportedNot reportedNot reportedNot reported
Cohort B0Not reportedNot reportedNot reportedNot reported
Cohort C0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A0Not reportedNot reportedNot reportedNot reported
Cohort B0Not reportedNot reportedNot reportedNot reported
Cohort C0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A0Not reportedNot reportedNot reportedNot reported
Cohort B0Not reportedNot reportedNot reportedNot reported
Cohort C5Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A1Not reportedNot reportedNot reportedNot reported
Cohort B4Not reportedNot reportedNot reportedNot reported
Cohort C1Not reportedNot reportedNot reportedNot reported
Not Assessed
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A0Not reportedNot reportedNot reportedNot reported
Cohort B1Not reportedNot reportedNot reportedNot reported
Cohort C4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Complete Repsonse
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
    title
    Progressive Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        4
    title
    Not Assessed
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      10
    units
    Participants
description
Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
groups
  1. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle
    id
    OG000
    title
    Cohort A
  2. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    id
    OG001
    title
    Cohort B
  3. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    id
    OG002
    title
    Cohort C
param Type
NUMBER
population Description
All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.
reporting Status
POSTED
time Frame
Baseline through progressive disease (Up to 7.36 months)
title
Number of Participants With Tumor Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice