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NCT01871805 · OUTCOME

Recommended Phase II Dose (RP2D): Phase I

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
mg
Interval / dispersion
Not reported
Time frame
Throughout Cycle 1 of Phase I (21 days)

What was measured

RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.

Analysis population: Phase I safety population

Groups in this outcome

Alectinib: Phase I

Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 600, 760, or 900 mg on Cycle 1 Day -3 and then received 600 mg BID dose 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: Phase I47

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Alectinib: Phase I600Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        600
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    units
    Participants
description
RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.
groups
  1. description
    Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 600, 760, or 900 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    OG000
    title
    Alectinib: Phase I
param Type
NUMBER
population Description
Phase I safety population
reporting Status
POSTED
time Frame
Throughout Cycle 1 of Phase I (21 days)
title
Recommended Phase II Dose (RP2D): Phase I
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice