Participant flow

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma · Source last updated 2019-08-28

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

groups

1. description

   The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

   id

   FG000

   title

   LDE225 (Sonidegib) 200 mg

2. description

   The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

   id

   FG001

   title

   LDE225 (Sonidegib) 800 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         57

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         35

      type

      Patient/guardian decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         14

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         5

      type

      Non-compliance with study treatment

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Study terminated by Sponsor

   8. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         26

      type

      Progressive disease

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   10. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Untreated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         79

      2. group Id

         FG001

         num Subjects

         151

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. comment

         one patient randomized to LDE225 (sonidegib) 800 mg did not receive study treatment

         group Id

         FG001

         num Subjects

         1

      type

      Untreated

   3. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         89

      type

      Patients Cont. to Next Phase of Trial

   4. achievements

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         49

      type

      Survival Follow-up

   5. achievements

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         40

      type

      Post-treatment Follow-up

   6. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         79

      2. group Id

         FG001

         num Subjects

         151

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

All eligible, enrolled patients were randomized in 1:2 ratio to sonidegib treatment with either 200 mg or 800 mg once-daily dose. In total, 230 patients were evaluated as FAS population: 79 and 151 patients randomized to 200mg and 800 mg sonidegib respectively. However, 1 patient randomized to 800 mg sonidegib did not receive study treatment.

recruitment Details

Randomization was stratified across the two treatment arms according to the stage of disease (laBCC or mBCC), histological subtype (non-aggressive or aggressive for laBCC patients) and the regions (Australia, Europe, and North America).

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Preserved source evidence · Not medical advice