Participant flow

Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia · Source last updated 2019-09-10

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

groups

1. description

   IMO-8400 0.6 mg/kg once weekly s.c.

   id

   FG000

   title

   IMO-8400 0.6 mg/kg 1x/wk

2. description

   IMO-8400 1.2 mg/kg once weekly s.c.

   id

   FG001

   title

   IMO-8400 1.2 mg/kg 1x/wk

3. description

   IMO-8400 1.2 mg/kg twice weekly s.c.

   id

   FG002

   title

   IMO-8400 1.2 mg/kg 2x/wk

4. description

   IMO-8400 2.4 mg/kg once weekly s.c.

   id

   FG003

   title

   IMO-8400 2.4 mg/kg 1x/wk

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      type

      Study terminated by Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      type

      Miscellaneous

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         14

      4. group Id

         FG003

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Screening occurred ≤ 21 days before Day 1 (the first injection of study drug).

recruitment Details

Patients were enrolled from 02 April 2014 through 31 March 2017 at 14 study sites in the United States.

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

Preserved source evidence · Not medical advice