Participant flow

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.

groups

1. description

   Participants received alectinib at a dose of 600 milligrams (mg) via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until disease progression (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

   FG000

   title

   Alectinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Other

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         27

      type

      Study Terminated by Sponsor

   7. reasons

      1. group Id

         FG000

         num Subjects

         81

      type

      Progressive Disease

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         138

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         138

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Part 1 of study was planned to determine recommended Phase 2 dose (RP2D) of alectinib to be used in Part 2. During the conduct of Part 1 for this study, RP2D was confirmed in Study NP28761 (NCT01871805). Hence Part 1 participants were merged into Part 2. Part 3 was post-progression treatment period.

recruitment Details

Overall study status was confirmed as completed. Here, 'study terminated by sponsor' in reason for study not completed means participants were transitioned to commercial supply of alectinib (where it was available) or transitioned to a roll-over study BO39694 (NCT03194893) where they continued to receive alectinib treatment.

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Preserved source evidence · Not medical advice