Participant flow

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11

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

groups

1. description

   Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle

   id

   FG000

   title

   Phase 1: Romidepsin 9mg/m^2

2. description

   Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

   id

   FG001

   title

   Phase 1: Romidepsin 14mg/m^2

3. description

   Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

   id

   FG002

   title

   Phase 2: Romidepsin 14mg/m^2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. comment

         Completed = on treatment

         group Id

         FG000

         num Subjects

         1

      2. comment

         Completed = on treatment

         group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Phase 1 (First Step)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         17

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         10

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      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

         1

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         40

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         7

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         33

      type

      NOT COMPLETED

   title

   Phase 2 (Second Step)

pre Assignment Details

Those with relapsed, recurring or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) were enrolled in the Phase 1 part of this study. In Phase 2, the target disease was relapsed, recurring or refractory PTCL only. Results are reported up to the data cut-off of 28 July 2015.

recruitment Details

This was a Phase 1/2 open-label dose-escalation study. Phase 1 part composed of Cohort 1 (9mg/m\^2) and Cohort 2 (14mg/m\^2). Japanese participants were enrolled in order from Cohort 1. The dose used in the Phase 2 part was determined based on the frequency of dose limiting toxicities in Phase 1.

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Preserved source evidence · Not medical advice