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NCT01801111 · OUTCOME

Recommended Phase 2 Dose (RP2D) of Alectinib

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment · Source last updated 2018-11-02

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycle 1 (up to 28 days)

What was measured

RP2D was to be determined based on the safety and tolerability profile of the study treatment.

Analysis population: The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).

Groups in this outcome

Alectinib

Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.

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

Analysis denominator · Participants

GroupSource count
Alectinib0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
RP2D was to be determined based on the safety and tolerability profile of the study treatment.
groups
  1. description
    Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
    id
    OG000
    title
    Alectinib
population Description
The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).
reporting Status
POSTED
time Frame
Cycle 1 (up to 28 days)
title
Recommended Phase 2 Dose (RP2D) of Alectinib
type
PRIMARY

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

Preserved source evidence · Not medical advice