Participant flow

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas · Source last updated 2019-11-25

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

groups

1. description

   Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest

   id

   FG000

   title

   Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)

2. description

   Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)

   id

   FG001

   title

   Gemcitabine (Gem)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         196

      2. group Id

         FG001

         num Subjects

         245

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         128

      2. group Id

         FG001

         num Subjects

         73

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         18

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         6

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         39

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         10

      type

      Other

   7. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         27

      type

      Withdrew prior to starting treatment

   milestones

   1. achievements

      1. comment

         Started = Intent to Treat Population and includes all randomized participants

         group Id

         FG000

         num Subjects

         431

      2. comment

         Started = Intent to Treat Population and includes all randomized participants

         group Id

         FG001

         num Subjects

         430

      type

      STARTED

   2. achievements

      1. comment

         Treated population = all randomized patients who received at least one dose of study drug

         group Id

         FG000

         num Subjects

         421

      2. comment

         Treated population = all randomized patients who received at least one dose of study drug

         group Id

         FG001

         num Subjects

         402

      type

      Treated Population

   3. achievements

      1. comment

         Completed = participants remaining on treatment at the time of the data cut off 17 Sept 2012

         group Id

         FG000

         num Subjects

         26

      2. comment

         Completed = participants remaining on treatment at the time of the data cut off 17 Sept 2012

         group Id

         FG001

         num Subjects

         12

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         405

      2. group Id

         FG001

         num Subjects

         418

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

38 participants were randomized but not treated due to the participants request to withdraw after the randomization results became known. 1 participant was randomized to Gemcitabine and was treated with Albumin-bound paclitaxel ABI-007/Gemcitabine in error and analyzed as treated and included in the intent to treat population (ITT)

recruitment Details

Participants were randomized in a 1:1 ratio and the randomization was stratified by geographic region (Australia versus Eastern Europe versus Western Europe versus North America), Karnofsky performance status (70 to 80 versus 90 to 100), and by the presence of liver metastases (yes versus no)

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Preserved source evidence · Not medical advice