Skip to content
← Full study record

NCT04165031 · OUTCOME

Phase 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD

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

DCR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed CR, confirmed PR, or SD out of all participants treatment. Best response is determined from a sequence of responses assessed. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. 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
DCR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed CR, confirmed PR, or SD out of all participants treatment. Best response is determined from a sequence of responses assessed. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. 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: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
type
SECONDARY

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

Preserved source evidence · Not medical advice