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NCT02549989 · OUTCOME

Clinical Benefit Rate (CBR)

Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer · Source last updated 2023-02-22

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
12 weeks from baseline up to a year

What was measured

defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) ≥12 weeks from the start of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Groups in this outcome

LY3023414

This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase II study to evaluate the activity of LY3023414 dosed at the RP2D of 200 mg orally twice daily in patients with recurrent or persistent endometrial cancer. LY3023414: Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination

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

Analysis denominator · Participants

GroupSource count
LY302341425

Reported measurements

Source class 1

Participants with Clinical Benefit Rate (CR+PR+SD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY30234147Not reportedNot reportedNot reportedNot reported

Participants without CBR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY302341418Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      title
      Participants with Clinical Benefit Rate (CR+PR+SD)
    2. measurements
      1. group Id
        OG000
        value
        18
      title
      Participants without CBR
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
defined as the percentage of patients with complete response (CR) + partial response (PR) + stable disease (SD) ≥12 weeks from the start of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    This is an MSKCC investigator-initiated, single-center, non-randomized, open-label, phase II study to evaluate the activity of LY3023414 dosed at the RP2D of 200 mg orally twice daily in patients with recurrent or persistent endometrial cancer. LY3023414: Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination
    id
    OG000
    title
    LY3023414
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
12 weeks from baseline up to a year
title
Clinical Benefit Rate (CBR)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice