Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02187783 · OUTCOME

Number of Participants With Solid Tumor Response ≥ 16 Weeks for Based Upon Local Investigator Assessments

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up ≥16 weeks up to approximately 36 months

What was measured

Clinical benefit (CB) for patients with solid tumors were assessed using RECIST 1.1 and included responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (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

Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg0Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg3Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg16Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg71Not reportedNot reportedNot reportedNot reported
Non-evaluable (NE)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib 600 mg15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Partial response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Stable disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        71
    title
    Progressive disease (PD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Non-evaluable (NE)
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    units
    Participants
description
Clinical benefit (CB) for patients with solid tumors were assessed using RECIST 1.1 and included responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (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
  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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Baseline up ≥16 weeks up to approximately 36 months
title
Number of Participants With Solid Tumor Response ≥ 16 Weeks for Based Upon Local Investigator Assessments
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice