Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04165031 · OUTCOME

Phase 1: ORR: Percentage of Participants Who Achieve CR or PR

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation · Source last updated 2021-11-24

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Baseline through Measured Progressive Disease (Up to 11 Months)

What was measured

ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.

Analysis population: Zero participants were analyzed due to early termination of study.

Groups in this outcome

LY3499446 Phase 1 Cohort A1 (High Dose)

Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.

LY3499446 Phase 1 Cohort AO (Mid Dose)

Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.

LY3499446 Phase 1 Cohort A-2 (Low Dose)

Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.

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

Analysis denominator · Participants

GroupSource count
LY3499446 Phase 1 Cohort A1 (High Dose)0
LY3499446 Phase 1 Cohort AO (Mid Dose)0
LY3499446 Phase 1 Cohort A-2 (Low Dose)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
groups
  1. description
    Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
    id
    OG000
    title
    LY3499446 Phase 1 Cohort A1 (High Dose)
  2. description
    Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
    id
    OG001
    title
    LY3499446 Phase 1 Cohort AO (Mid Dose)
  3. description
    Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
    id
    OG002
    title
    LY3499446 Phase 1 Cohort A-2 (Low Dose)
population Description
Zero participants were analyzed due to early termination of study.
reporting Status
POSTED
time Frame
Baseline through Measured Progressive Disease (Up to 11 Months)
title
Phase 1: ORR: Percentage of Participants Who Achieve CR or PR
type
SECONDARY

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

Preserved source evidence · Not medical advice