Participant flow

First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone · Source last updated 2023-03-24

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

groups

1. description

   Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.

   id

   FG000

   title

   M3258 10 mg QD

2. description

   Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.

   id

   FG001

   title

   M3258 10 mg Twice Per Week

3. description

   Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.

   id

   FG002

   title

   M3258 20 mg Twice Per Week

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. comment

         1 participant received actual dose of 10 mg in Cycle 1 Day 1 instead of planned 20 mg and was summarized with the 10 mg dose level for PK analysis set.

         group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         3

      type

      Pharmacokinetic (PK) Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. comment

         1 participant received actual dose of 10 mg in Cycle 1 Day 1 instead of planned 20 mg and was summarized with the 10 mg dose level for Pd analysis set.

         group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         3

      type

      Pharmacodynamics (Pd) Analysis Set

   4. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

This study was planned to be conducted in 2 parts; Part A: Dose escalation part and Part B: Dose expansion part. However, because of early discontinuation, only Part A was conducted; due to lack of participant enrollment before Part A reached its primary objective and before Part B was started.

recruitment Details

First participant signed informed consent: 26 September 2019, Last participant last visit: 01 April 2021.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice