Participant flow

Study of INCB053914 in Subjects With Advanced Malignancies · Source last updated 2021-12-08

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

groups

1. description

   INCB053914 was self-administered orally once a day as a 100mg immediate release monotherapy dose.

   id

   FG000

   title

   Parts 1 and 2: INCB053914 100 mg QD

2. description

   INCB053914 was self-administered orally twice day as a 50mg immediate release monotherapy dose.

   id

   FG001

   title

   Parts 1 and 2: INCB053914 50 mg BID

3. description

   INCB053914 was self-administered orally twice day as a 65mg immediate release monotherapy dose.

   id

   FG002

   title

   Parts 1 and 2: INB053914 65 mg BID

4. description

   INCB053914 was self-administered orally twice day as a 80mg immediate release monotherapy dose.

   id

   FG003

   title

   Parts 1 and 2: INB053914 80 mg BID

5. description

   INCB053914 was self-administered orally twice day as a 100mg immediate release monotherapy dose.

   id

   FG004

   title

   Parts 1 and 2: INB053914 100 mg BID

6. description

   INCB053914 was self-administered orally twice day as a 115mg immediate release monotherapy dose.

   id

   FG005

   title

   Parts 1 and 2: INB053914 115 mg BID

7. description

   Combination Treatment Group A: 50 mg twice a day + I-DAC (intermediate dose cytarabine) was administered at a dose of 1 g/m2 as an infusion as a combination therapy with INCB053914.

   id

   FG006

   title

   Parts 3 and 4: INCB053914 50 mg BID + Cytarabine

8. description

   Combination Treatment Group B: INCB053914 50 mg twice a day + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.

   id

   FG007

   title

   Parts 3 and 4: INCB053914 50 mg BID + Azacitidine

9. description

   Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.

   id

   FG008

   title

   Part 3 and 4 - INCB053914 80 mg BID + Azacitidine

10. description

    Combination Treatment Group C: INCB053914 50 mg + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.

    id

    FG009

    title

    Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib

11. description

    Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.

    id

    FG010

    title

    Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         16

      5. group Id

         FG004

         num Subjects

         9

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         7

      9. group Id

         FG008

         num Subjects

         9

      10. group Id

          FG009

          num Subjects

          1

      11. group Id

          FG010

          num Subjects

          3

      type

      Death

   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

         3

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          1

      11. group Id

          FG010

          num Subjects

          6

      type

      Study Terminated by the Sponsor

   3. 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

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      type

      Reason for study withdrawal not specified

   4. 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

         2

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          1

      11. group Id

          FG010

          num Subjects

          2

      type

      Withdrawal by Subject

   5. 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

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          3

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         21

      5. group Id

         FG004

         num Subjects

         12

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         7

      9. group Id

         FG008

         num Subjects

         9

      10. group Id

          FG009

          num Subjects

          3

      11. group Id

          FG010

          num Subjects

          14

      type

      STARTED

   2. achievements

      1. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG000

         num Subjects

         0

      2. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG001

         num Subjects

         0

      3. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG002

         num Subjects

         0

      4. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG003

         num Subjects

         0

      5. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG004

         num Subjects

         0

      6. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG005

         num Subjects

         0

      7. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG006

         num Subjects

         0

      8. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG007

         num Subjects

         0

      9. comment

         All participants discontinued study treatment and withdrew from the study.

         group Id

         FG008

         num Subjects

         0

      10. comment

          All participants discontinued study treatment and withdrew from the study.

          group Id

          FG009

          num Subjects

          0

      11. comment

          All participants discontinued study treatment and withdrew from the study.

          group Id

          FG010

          num Subjects

          0

      comment

      All participants in each arm discontinued study treatment and withdrew from the study.

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         21

      5. group Id

         FG004

         num Subjects

         12

      6. group Id

         FG005

         num Subjects

         6

      7. group Id

         FG006

         num Subjects

         6

      8. group Id

         FG007

         num Subjects

         7

      9. group Id

         FG008

         num Subjects

         9

      10. group Id

          FG009

          num Subjects

          3

      11. group Id

          FG010

          num Subjects

          14

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 58 participants were enrolled and treated in Parts 1 and 2 combined and were included in the safety population and the full analysis set. A total of 39 participants enrolled and treated in Parts 3 and 4 combined were included in the safety population and the full analysis set.

recruitment Details

This study was conducted in 18 US centers and consisted of 4 parts: Parts 1 and 2 evaluated INCB053914 as a monotherapy, and Parts 3 and 4 evaluated INCB053914 as part of a combination therapy with select standard-of-care agents (cytarabine, azacitidine, and ruxolitinib) in participants with advanced malignancies. Note:The study was terminated early based on strategic business decisions and not due to concerns with the safety and tolerability of INCB053914.

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Preserved source evidence · Not medical advice