Participant flow

Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment · Source last updated 2019-06-10

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

groups

1. description

   Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.

   id

   FG000

   title

   Normal Renal Function: Ixazomib

2. description

   Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.

   id

   FG001

   title

   Severe Renal Impairment: Ixazomib

3. description

   Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.

   id

   FG002

   title

   End-stage Renal Disease: Ixazomib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         7

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Study Terminated by Sponsor

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Symptomatic Deterioration

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Reason not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         7

      type

      STARTED

   2. achievements

      1. comment

         Participants are considered to have completed study treatment if they are PK evaluable.

         group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         6

      type

      Pharmacokinetic-Evaluable Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         7

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with a diagnosis of relapsed or refractory multiple myeloma (RRMM) or advanced solid tumors who had normal renal function or severe renal impairment including end-stage renal disease requiring hemodialysis (ESRD) were enrolled to receive ixazomib orally in the study.

recruitment Details

Participants took part in the study at 6 investigative sites in the United States and Canada from 16 September 2013 up to 18 November 2016.

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Preserved source evidence · Not medical advice