Participant flow

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors · Source last updated 2024-12-27

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

groups

1. description

   Dose escalation of rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in combination with paclitaxel administered by intravenous (IV) infusion at 80 mg/meter squared (m\^2) on days 1, 8, and 15 of repeated 28-day cycles.

   id

   FG000

   title

   Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

2. description

   Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

   id

   FG001

   title

   Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2

3. description

   Dose expansion in triple-negative breast cancer (TNBC). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

   id

   FG002

   title

   Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

4. description

   Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

   id

   FG003

   title

   Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2

5. description

   Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

   id

   FG004

   title

   Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

6. description

   Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

   id

   FG005

   title

   Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2

7. description

   Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 repeated 28-day cycles.

   id

   FG006

   title

   Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

8. description

   Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

   id

   FG007

   title

   Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2

9. description

   Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

   id

   FG008

   title

   Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

10. description

    Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

    id

    FG009

    title

    Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2

11. description

    Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

    id

    FG010

    title

    Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         19

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         15

      6. group Id

         FG005

         num Subjects

         5

      7. group Id

         FG006

         num Subjects

         28

      8. group Id

         FG007

         num Subjects

         10

      9. group Id

         FG008

         num Subjects

         22

      10. group Id

          FG009

          num Subjects

          16

      11. group Id

          FG010

          num Subjects

          20

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         13

      6. group Id

         FG005

         num Subjects

         4

      7. group Id

         FG006

         num Subjects

         26

      8. group Id

         FG007

         num Subjects

         9

      9. group Id

         FG008

         num Subjects

         20

      10. group Id

          FG009

          num Subjects

          14

      11. group Id

          FG010

          num Subjects

          19

      comment

      Modified Intent-to-Treat (mITT) Population includes all participants who had at least one dose of the combined study drugs, had measurable disease at baseline, and had at least one post-baseline assessment. Participants without a post-baseline assessment who discontinued study treatment due to clinical progression, death, or a rebastinib-related AE will also be included in the mITT population.

      type

      mITT Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         9

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         12

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         9

      10. group Id

          FG009

          num Subjects

          5

      11. group Id

          FG010

          num Subjects

          7

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         16

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         13

      10. group Id

          FG009

          num Subjects

          11

      11. group Id

          FG010

          num Subjects

          13

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice