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Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor · Source last updated 2014-11-21

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

groups

1. description

   Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.

   id

   FG000

   title

   Octreotide+ Everolimus

2. description

   Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.

   id

   FG001

   title

   Octreotide+ Placebo Followed by Open Label Arm

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         101

      2. group Id

         FG001

         num Subjects

         154

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         61

      2. group Id

         FG001

         num Subjects

         16

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         14

      type

      Final Primary Analysis

   4. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         20

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      type

      Protocol Violation

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      New Cander Therapy

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         216

      2. group Id

         FG001

         num Subjects

         213

      type

      STARTED

   2. achievements

      1. comment

         1 patient did not provide at laest one valid post baseline safety assessment.

         group Id

         FG000

         num Subjects

         215

      2. comment

         1 pt randomized never took drug Another randomized did not have valid post BL safety assessment

         group Id

         FG001

         num Subjects

         211

      type

      Safety Set

   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

         216

      2. group Id

         FG001

         num Subjects

         213

      type

      NOT COMPLETED

   title

   Double Blind Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         86

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         46

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         15

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         13

      type

      Administrative Problems

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         7

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      New Cancer Therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         170

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         170

      type

      NOT COMPLETED

   title

   Open Label Phase

pre Assignment Details

Total 429 patients were randomized to double blind phase of treatment. 170 patients moved to the Open Label Phase.

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Preserved source evidence · Not medical advice