Participant flow

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer · Source last updated 2024-11-26

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

groups

1. description

   Non-randomized cohort. Participants received Tucatinib 300 milligrams (mg) orally (PO) twice daily (BID) on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 milligram/kilogram (mg/kg) by intravenous (IV) infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until progressive disease (PD), death, withdrawal of consent, study closure, or alternative therapy.

   id

   FG000

   title

   Tucatinib+Trastuzumab (Cohort A)

2. description

   Randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.

   id

   FG001

   title

   Tucatinib+Trastuzumab (Cohort B)

3. description

   Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab until PD, death, withdrawal of consent, study closure, or alternative therapy based on radiographic progression (as determined by investigator assessment using response evaluation criteria in solid tumors \[RECIST\] version \[v\] 1.1), or if they had not achieved a partial response (PR) or complete response (CR) by the week 12 assessment.

   id

   FG002

   title

   Tucatinib Monotherapy (Cohort C)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         26

      3. group Id

         FG002

         num Subjects

         17

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         13

      type

      Participation terminated by sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         31

      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

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         31

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 117 participants were enrolled at a total of 56 sites in the United States, Italy, France, Belgium, and Spain. The date of first participant enrollment was 23-Jun-2017. The date of last participant randomization was 02-Nov-2023.

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

Preserved source evidence · Not medical advice