Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01871805 · OUTCOME

Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2018-08-21

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)

What was measured

Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.

Analysis population: Phase II RE population

Groups in this outcome

Alectinib 600 mg (Fed): Phase II

Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

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

Analysis denominator · Participants

GroupSource count
Alectinib 600 mg (Fed): Phase II87

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Alectinib 600 mg (Fed): Phase II52.9Not reported41.8763.67Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0010
    p Value Comment
    Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
    statistical Method
    Exact Clopper-Pearson CI, 2 sided
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0010
    p Value Comment
    Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
    statistical Method
    Exact Clopper-Pearson CI, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.87
        upper Limit
        63.67
        value
        52.9
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    units
    Participants
description
Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    OG000
    title
    Alectinib 600 mg (Fed): Phase II
param Type
NUMBER
population Description
Phase II RE population
reporting Status
POSTED
time Frame
Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
title
Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice