Participant flow

Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium · Source last updated 2014-05-30

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

groups

1. description

   Sorafenib was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If sorafenib was taken with meals, patients were instructed to take sorafenib tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies. Patients were instructed to keep a pill diary and record the pills they took each day.

   id

   FG000

   title

   TCC (Transitional Cell Carcinoma) Cohort

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Ineligibility

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Alternative treatment

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      performance status was deteiorating

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         27

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         22

      type

      Eligible and Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         15

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         12

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The study was activated on 10/26/2005. The TCC (transitional cell carcinoma) cohort was suspended for an efficacy evaluation on 10/30/2006 after reaching its first stage accrual goal. A total of 27 patients entered the TCC cohort, and no patient entered the non-TCC cohort. The study was terminated on March 10th, 2008.

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Preserved source evidence · Not medical advice