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NCT02187783 · OUTCOME

Clinical Benefit Rate (CBR) of ≥ 16 Weeks FAS

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) · Source last updated 2019-07-18

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

Measure
NUMBER
Unit
participant
Interval / dispersion
95% Confidence Interval
Time frame
Baseline and ≥ 16 weeks up to approximately 36 months

What was measured

CBR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR + PR + SD for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm FAS

Groups in this outcome

Ribociclib 600 mg

LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.

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

Analysis denominator · Participants

GroupSource count
Ribociclib 600 mg105

Reported measurements

Source class 1
Values in participant · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg19Not reported11.326.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.3
        upper Limit
        26.8
        value
        19
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    units
    Participants
description
CBR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR + PR + SD for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm FAS
dispersion Type
95% Confidence Interval
groups
  1. description
    LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
    id
    OG000
    title
    Ribociclib 600 mg
param Type
NUMBER
reporting Status
POSTED
time Frame
Baseline and ≥ 16 weeks up to approximately 36 months
title
Clinical Benefit Rate (CBR) of ≥ 16 Weeks FAS
type
PRIMARY
unit Of Measure
participant

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

Preserved source evidence · Not medical advice