Participant flow

Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM) · Source last updated 2020-03-17

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

groups

1. description

   During Combination Treatment Phase, participants received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m\^2) and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

   id

   FG000

   title

   Amatuximab + Pemetrexed + Cisplatin

2. description

   During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.

   id

   FG001

   title

   Placebo + Pemetrexed + Cisplatin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Progressive Disease (Radiographic test)

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Progressive Disease(Clinical assessment)

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Investigator Discretion

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Test Article Held (Greater than 21 Days)

   6. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         4

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         12

      type

      Sponsor Decision

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Other

   10. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          2

       type

       Not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         56

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         54

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         29

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         27

      type

      NOT COMPLETED

   title

   Combination Treatment Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         10

      type

      Progressive Disease (Radiographic test)

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         0

      type

      Test Article Held (Greater than 21 Days)

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse Event

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         15

      type

      Sponsor Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Not Treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         29

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         29

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         29

      type

      NOT COMPLETED

   title

   Maintenance Treatment Phase

pre Assignment Details

A total of 124 participants were enrolled (signed informed consent form), of which, 16 were screen failures, 108 were randomized, and 106 were treated. Deaths that were primary cause of treatment discontinuation are reported in participant flow excluding those that occurred after treatment discontinuation.

recruitment Details

Participants took part in the study at 36 investigative sites in the United States, France, Germany, Italy, the United Kingdom, and Australia from 03 November 2015 to 30 November 2018.

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

Preserved source evidence · Not medical advice