Participant flow

Nintedanib (BIBF 1120) in Mesothelioma · Source last updated 2019-03-18

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

groups

1. description

   Phase II part: Nintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

   id

   FG000

   title

   Placebo_Phase II

2. description

   Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

   id

   FG001

   title

   Nintedanib_Phase II

3. description

   Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

   id

   FG002

   title

   Placebo_Phase III

4. description

   Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.

   id

   FG003

   title

   Nintedanib_Phase III

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         32

      3. group Id

         FG002

         num Subjects

         95

      4. group Id

         FG003

         num Subjects

         92

      type

      PD based on modified RECIST criteria

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         13

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Protocol Violation

   4. 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

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      type

      Not treated

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         6

      type

      Other than reasons specified

   7. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         22

      4. group Id

         FG003

         num Subjects

         23

      type

      Adverse event (AE)

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         8

      4. group Id

         FG003

         num Subjects

         8

      type

      Worsening/AE underlying cancer disease

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         44

      3. group Id

         FG002

         num Subjects

         229

      4. group Id

         FG003

         num Subjects

         229

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         44

      3. group Id

         FG002

         num Subjects

         228

      4. group Id

         FG003

         num Subjects

         227

      type

      Treated Patients

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         82

      4. group Id

         FG003

         num Subjects

         83

      comment

      On treatment or completed according to protocol at the time of analysis

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         40

      3. group Id

         FG002

         num Subjects

         147

      4. group Id

         FG003

         num Subjects

         146

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

All participants were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the participants) met all implemented inclusion/exclusion criteria. Participants were not to be entered to trial if any of the specific entry criteria was violated. PD: Progressive Disease

recruitment Details

Patients were initially treated with combination therapy consisting of nintedanib or placebo plus standard chemotherapy (pemetrexed/cisplatin), for a maximum of 6 cycles of 21 days duration. After completion of combination therapy, patients who had not progressed continued with nintedanib or placebo monotherapy.

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Preserved source evidence · Not medical advice