Participant flow

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

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

groups

1. description

   Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

   id

   FG000

   title

   Combined Safety Lead-in

2. description

   Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

   id

   FG001

   title

   Phase 3: Triplet Arm

3. description

   Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.

   id

   FG002

   title

   Phase 3: Doublet Arm

4. description

   Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

   id

   FG003

   title

   Phase 3: Control Arm

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         0

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         209

      3. group Id

         FG002

         num Subjects

         193

      4. group Id

         FG003

         num Subjects

         198

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         20

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         3

      type

      Study participation terminated by sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         0

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         224

      3. group Id

         FG002

         num Subjects

         220

      4. group Id

         FG003

         num Subjects

         221

      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. comment

         Participants from control arm received triplet therapy.

         group Id

         FG003

         num Subjects

         3

      type

      Crossover Participants

   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

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         224

      3. group Id

         FG002

         num Subjects

         220

      4. group Id

         FG003

         num Subjects

         221

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants were at least 18 years of age with confirmed metastatic colorectal cancer (CRC) whose disease had progressed after 1 or 2 prior regimens in the metastatic setting and whose tumor tissue was BRAF V600E-mutant as previously determined by a local assay at any time prior to Screening.

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

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