Participant flow

Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin · Source last updated 2023-10-04

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

groups

1. description

   Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous ADI-PEG 20 plus Pem Platinum: Investigational Drug in combination approved standard of care treatment for this indication

   id

   FG000

   title

   Drug: ADI-PEG 20 Plus Pem Platinum

2. description

   Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Carboplatin Dose: AUC 5 mg/mL/min every 3 weeks Route of Administration: Intravenous Placebo plus Pem Platinum: Placebo in combination approved standard of care treatment for this indication

   id

   FG001

   title

   Drug: Placebo Plus Pem Platinum

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         87

      2. group Id

         FG001

         num Subjects

         89

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         87

      2. group Id

         FG001

         num Subjects

         89

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Phase 2

2. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         125

      2. group Id

         FG001

         num Subjects

         124

      type

      STARTED

   2. achievements

      1. comment

         For Phase 3 the total number of subjects enrolled included 87 subjects from Phase 2 that counted towards 125 enrolled subjects on this arm.

         group Id

         FG000

         num Subjects

         125

      2. comment

         For Phase 3 the total number of subjects enrolled included 89 subjects from Phase 2 that counted towards 124 enrolled subjects on this arm.

         group Id

         FG001

         num Subjects

         124

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Phase 3

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

Preserved source evidence · Not medical advice