Participant flow

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) · Source last updated 2023-06-22

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

groups

1. description

   Participants received lenvatinib 24 milligram (mg), hard capsule, orally, once daily, until documentation of disease progression (confirmed by Investigator-Initiated Research \[IIR\]), development of unacceptable toxicity, or withdrawal of consent.

   id

   FG000

   title

   Randomization Phase: Lenvatinib 24 mg

2. description

   Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

   id

   FG001

   title

   Randomization Phase: Placebo

3. description

   Participants received lenvatinib 24 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. OOL refers to Optional Open-Label.

   id

   FG002

   title

   OOL, Treatment Period: Lenvatinib 24 mg

4. description

   Participants received lenvatinib 20 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.

   id

   FG003

   title

   OOL, Treatment Period: Lenvatinib 20 mg

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         261

      2. group Id

         FG001

         num Subjects

         131

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         261

      2. group Id

         FG001

         num Subjects

         131

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Randomization Phase

2. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. comment

         Participants from randomization phase were re-randomized to OOL, treatment period.

         group Id

         FG002

         num Subjects

         85

      4. comment

         Participants from randomization phase were re-randomized to OOL, treatment period.

         group Id

         FG003

         num Subjects

         30

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         85

      4. group Id

         FG003

         num Subjects

         30

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   OOL Lenvatinib Treatment Period

pre Assignment Details

A total of 612 participants were screened for entry into the study. Of these 612 participants, 220 participants were screening failures and 392 participants were randomly assigned to receive either lenvatinib or placebo in a 2:1 ratio.

recruitment Details

Participants took part in the study at 117 investigative sites in Europe, North America, Asia Pacific, Japan, and Latin America from 17 March 2011 to 19 March 2019.

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Preserved source evidence · Not medical advice