Participant flow

An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer · Source last updated 2025-09-24

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

groups

1. description

   Participants received vandetanib 300 mg orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period. Upon disease progression or implementation of protocol amendment 6, participants who were unblinded were given the option to enter the open-label treatment period and continue to receive vandetanib 300 mg orally once daily for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy.

   id

   FG000

   title

   Vandetanib 300 mg/Vandetanib 300 mg

2. description

   Participants received placebo matched to vandetanib orally once daily until objective disease progression, any other withdrawal criteria was met or at the investigator's discretion, the approval and implementation of protocol amendment 6 during the blinded randomized treatment period. Upon disease progression or implementation of protocol amendment 6, participants who were unblinded were given the option to enter the open-label treatment period and receive vandetanib 300 mg orally once daily for as long as they still benefitted of it per investigator judgement or until they were given another anti-cancer therapy.

   id

   FG001

   title

   Placebo/Vandetanib 300 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         34

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         103

      2. group Id

         FG001

         num Subjects

         68

      type

      Objective Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         21

      type

      Other

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Randomized but did not Receive Treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         231

      2. group Id

         FG001

         num Subjects

         100

      comment

      Randomized participants.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         231

      2. group Id

         FG001

         num Subjects

         99

      type

      Received Randomized Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         1

      comment

      Participants who ended randomized treatment.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         217

      2. group Id

         FG001

         num Subjects

         99

      type

      NOT COMPLETED

   title

   Randomized Treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         15

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         27

      type

      Objective Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         9

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         109

      2. group Id

         FG001

         num Subjects

         79

      comment

      Participants who discontinued randomized treatment and received open-label treatment (vandetanib 300 mg).

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         21

      comment

      Participants who ended open-label treatment (vandetanib 300 mg).

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         81

      2. group Id

         FG001

         num Subjects

         58

      type

      NOT COMPLETED

   title

   Open-Label Treatment Period

recruitment Details

A total of 331 participants were enrolled in the study. The study was conducted at 60 study sites in 23 countries. First participant enrolled 23 November 2006, last participant enrolled 19 October 2007.

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Preserved source evidence · Not medical advice