Participant flow

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations · Source last updated 2021-07-14

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

groups

1. description

   Participants treated with trametinib 0.0125 mg/kg/day

   id

   FG000

   title

   Part A - TMT 0.0125 mg/kg/Day

2. description

   Participants treated with trametinib 0.025 mg/kg/day

   id

   FG001

   title

   Part A - TMT 0.025 mg/kg/Day

3. description

   Participants under 6 years of age treated with trametinib 0.032 mg/kg/day

   id

   FG002

   title

   Part A - TMT 0.032 mg/kg/Day

4. description

   Participants treated with trametinib 0.04 mg/kg/day

   id

   FG003

   title

   Part A - TMT 0.04 mg/kg/Day

5. description

   Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day

   id

   FG004

   title

   Part B - Neuroblastoma

6. description

   Participants with refractory or relapsed neuroblastoma treated with trametinib 0.025 mg/kg/day

   id

   FG005

   title

   Part B - LGG Fusion

7. description

   Participants with neurofibromatosis Type -1 associated plexiform neurofibromas (NF-1 with PN) treated with trametinib 0.025 mg/kg/day

   id

   FG006

   title

   Part B - NF-1 With PN

8. description

   Participants with BRAF V600 mutant solid tumors treated with trametinib 0.025 mg/kg/day

   id

   FG007

   title

   Part B - BRAF V600 Mutant Solid Tumor

9. description

   Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)

   id

   FG008

   title

   Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D

10. description

    Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)

    id

    FG009

    title

    Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D

11. description

    Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)

    id

    FG010

    title

    Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D

12. description

    Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)

    id

    FG011

    title

    Part D - LGG

Show more (12 of 13)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         2

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          1

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 13)

      type

      Lack of Efficacy

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         5

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          3

      11. group Id

          FG010

          num Subjects

          1

      12. group Id

          FG011

          num Subjects

          3

      Show more (12 of 13)

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      7. group Id

         FG006

         num Subjects

         1

      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

          0

      12. group Id

          FG011

          num Subjects

          1

      Show more (12 of 13)

      type

      Withdrawal consent

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      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

          0

      12. group Id

          FG011

          num Subjects

          1

      Show more (12 of 13)

      type

      Investigator discretion

   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

         1

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         0

      10. group Id

          FG009

          num Subjects

          0

      11. group Id

          FG010

          num Subjects

          0

      12. group Id

          FG011

          num Subjects

          0

      Show more (12 of 13)

      type

      Progressive disease

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         4

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          1

      11. group Id

          FG010

          num Subjects

          1

      12. group Id

          FG011

          num Subjects

          1

      Show more (12 of 13)

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         19

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         16

      5. group Id

         FG004

         num Subjects

         11

      6. group Id

         FG005

         num Subjects

         10

      7. group Id

         FG006

         num Subjects

         10

      8. group Id

         FG007

         num Subjects

         10

      9. group Id

         FG008

         num Subjects

         3

      10. group Id

          FG009

          num Subjects

          9

      11. group Id

          FG010

          num Subjects

          6

      12. group Id

          FG011

          num Subjects

          20

      Show more (12 of 13)

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         2

      7. group Id

         FG006

         num Subjects

         2

      8. group Id

         FG007

         num Subjects

         1

      9. group Id

         FG008

         num Subjects

         2

      10. group Id

          FG009

          num Subjects

          2

      11. group Id

          FG010

          num Subjects

          4

      12. group Id

          FG011

          num Subjects

          14

      Show more (12 of 13)

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         13

      5. group Id

         FG004

         num Subjects

         9

      6. group Id

         FG005

         num Subjects

         8

      7. group Id

         FG006

         num Subjects

         8

      8. group Id

         FG007

         num Subjects

         9

      9. group Id

         FG008

         num Subjects

         1

      10. group Id

          FG009

          num Subjects

          7

      11. group Id

          FG010

          num Subjects

          2

      12. group Id

          FG011

          num Subjects

          6

      Show more (12 of 13)

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The participants were screened within 14 days prior to enrollment. After screening, the treatment period started on Cycle 1 Day 1.

recruitment Details

Participants took part in 16 investigative sites in 5 countries.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice