Participant flow

Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) · Source last updated 2023-02-06

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

groups

1. description

   Participants received GSK3326595 400 milligram (mg), tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

   id

   FG000

   title

   Part 1: GSK3326595 400 mg

2. description

   Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

   id

   FG001

   title

   Part 1: GSK3326595 300 mg

3. description

   Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.

   id

   FG002

   title

   Part 2-Dose Escalation: GSK3326595+5-Azacitidine

4. description

   Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.

   id

   FG003

   title

   Part 2-Dose Expansion: GSK3326595+5-Azacitidine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Study Terminated By Sponsor

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         17

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Part 1 (Up to 30.8 Months)

2. milestones

   1. achievements

      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

         0

      type

      STARTED

   2. achievements

      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

         0

      type

      COMPLETED

   3. achievements

      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

         0

      type

      NOT COMPLETED

   title

   Part 2 (Up to 3 Years and 2 Months)

pre Assignment Details

A total 30 participants were enrolled in Part 1. Part 2 was terminated early following a review of clinical data collected across the GSK3326595 clinical development program. Hence, no participants were enrolled in Part 2. The decision to terminate the study was not related to new safety concerns or to a change in the benefit risk profile of GSK3326595 .

recruitment Details

This was a 2-part study in participants with myeloid malignancies. Part 1 determined the clinical activity of GSK3326595 as monotherapy. Part 2 composed of a dose escalation and dose expansion cohorts to evaluate safety and clinical activity of GSK3326595 in combination with 5-Azacitidine

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Preserved source evidence · Not medical advice