Participant flow

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers · Source last updated 2023-08-21

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

groups

1. description

   All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

   id

   FG000

   title

   Anaplastic Thyroid Cancer (ATC)

2. description

   All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

   id

   FG001

   title

   Biliary Tract Cancer (BTC)

3. description

   All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

   id

   FG002

   title

   Gastrointestinal Stromal Tumor (GIST)

4. description

   All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

   id

   FG003

   title

   Low Grade (WHO G1/G2) Glioma (LGG)

5. description

   All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

   id

   FG004

   title

   High Grade (WHO G3/G4) Glioma (HGG)

6. description

   All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

   id

   FG005

   title

   Adenocarcinoma of the Small Intestine (ASI)

7. description

   All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

   id

   FG006

   title

   Hairy Cell Leukemia (HCL)

8. description

   All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

   id

   FG007

   title

   Multiple Myeloma (MM)

periods

1. drop Withdraws

   1. 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

         2

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         0

      type

      Physician Decision

   2. 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

      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

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         7

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         3

      8. group Id

         FG007

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         7

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         42

      8. group Id

         FG007

         num Subjects

         0

      type

      Study closed by sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         43

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         13

      5. group Id

         FG004

         num Subjects

         45

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         55

      8. group Id

         FG007

         num Subjects

         10

      comment

      All enrolled participants were included in the Intent-to-treat (ITT), All-treated subjects (ATS) and ITT/Evaluable populations

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         18

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         13

      5. group Id

         FG004

         num Subjects

         24

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         24

      8. group Id

         FG007

         num Subjects

         10

      type

      Primary Analysis Cohort

   3. achievements

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         25

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         21

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         31

      8. group Id

         FG007

         num Subjects

         0

      type

      Expansion Cohort

   4. achievements

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         34

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         28

      6. group Id

         FG005

         num Subjects

         3

      7. group Id

         FG006

         num Subjects

         8

      8. group Id

         FG007

         num Subjects

         9

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         9

      5. group Id

         FG004

         num Subjects

         17

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         47

      8. group Id

         FG007

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Subjects were enrolled into cohorts based on the type of histology. For each histology, up to 25 patients were planned to be enrolled. A cohort could be closed or stopped early (prior to capping at 25 patients) for futility or efficacy. An uncapped expansion cohort was planned when a particular cohort was stopped early for efficacy.

recruitment Details

The study was conducted in 41 centers in 14 countries worldwide.

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

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