Participant flow

A Study to Evaluate the Efficacy of Brigatinib (AP26113) in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib · Source last updated 2021-03-15

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

groups

1. description

   Brigatinib 90 mg, tablets, orally, once daily in each Cycle of 28 days until disease progression or intolerable toxicity (median duration of exposure was 402 days).

   id

   FG000

   title

   Brigatinib 90 mg

2. description

   Brigatinib 90 mg, tablets, orally, once daily for 7 days followed by brigatinib 180 mg, orally once daily in Cycle 1 of 28 days followed by brigatinib 180 mg, orally once daily in Cycle 2 and onward Cycles of 28 days until disease progression or intolerable toxicity (median duration of exposure was 522 days).

   id

   FG001

   title

   Brigatinib 90 mg - 180 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         14

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         13

      type

      Clinical Progressive Disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         63

      2. group Id

         FG001

         num Subjects

         50

      type

      Documented Progressive Disease (RECIST 1.1)

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Non-compliance with Study Drug

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Subject Received a New Systemic Anticancer Therapy

   7. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      type

      Physician Decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         17

      type

      Site Terminated by Sponsor

   9. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   10. reasons

       1. group Id

          FG000

          num Subjects

          3

       2. group Id

          FG001

          num Subjects

          0

       type

       Randomized but not Treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         112

      2. group Id

         FG001

         num Subjects

         110

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         109

      2. group Id

         FG001

         num Subjects

         110

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      comment

      Completed = Participants who completed the treatment.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         112

      2. group Id

         FG001

         num Subjects

         110

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with diagnosis of anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC) who had progressed on crizotinib were enrolled to receive brigatinib 90 mg, once daily or brigatinib 90-180 mg, once daily.

recruitment Details

Participants took part in the study at 71 investigative sites in the United States, Canada, Europe, Australia, and Asia from 04 Jun 2014 to 27 February 2020.

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

Preserved source evidence · Not medical advice