Participant flow

Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma · Source last updated 2023-07-11

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

groups

1. description

   Participants(age group 2 to\<6 years and 6 to\<18 years)with relapsed or refractory solid malignant tumors received lenvatinib 11mg/m\^2(per BSA, daily dose capped at 24 milligram per day\[mg/day\])as capsules or suspension(lenvatinib capsules dissolved in water/apple juice for participants who were unable to swallow capsules and given as suspension),orally,once daily on Days 1 to 28 of each treatment cycle until progressive disease(PD),intolerable toxicity,participant noncompliance with safety/efficacy assessments,initiation of another anticancer therapy,voluntary discontinuation by participant at any time,or study termination by sponsor,whichever occurred first. Eligible participants of age group 2 to\<6 years first underwent 21days run-in period with lenvatinib 5mg/m\^2,once daily before receiving lenvatinib11 mg/m\^2 in Cycle1 in Cohort1. Duration of each treatment cycle in Cohort1=28 days.After determining recommended dose(RD)in Cohort1,participants were enrolled in Cohorts 2A,2B and 3A.

   id

   FG000

   title

   Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2

2. description

   Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 14 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.

   id

   FG001

   title

   Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2

3. description

   Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days. After determining the RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.

   id

   FG002

   title

   Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2

4. description

   Participants with 131 iodine-refractory differentiated thyroid cancer (DTC) received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.

   id

   FG003

   title

   Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2

5. description

   Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.

   id

   FG004

   title

   Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2

6. description

   Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20 percent \[%\] lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 milligram per square meter per day (mg/m\^2/day) intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.

   id

   FG005

   title

   Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2

7. description

   Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.

   id

   FG006

   title

   Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2

8. description

   Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.

   id

   FG007

   title

   Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         27

      6. group Id

         FG005

         num Subjects

         7

      7. group Id

         FG006

         num Subjects

         9

      8. group Id

         FG007

         num Subjects

         14

      type

      Death

   2. reasons

      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

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         1

      8. group Id

         FG007

         num Subjects

         2

      type

      Withdrawal of Consent

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         31

      6. group Id

         FG005

         num Subjects

         7

      7. group Id

         FG006

         num Subjects

         15

      8. group Id

         FG007

         num Subjects

         20

      comment

      The Participants Flow module (including deaths in reasons for not completed) presentation is based on full analysis set. (Full analysis set included all enrolled participants who did not fail study screening).

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      8. group Id

         FG007

         num Subjects

         0

      type

      Underwent Run-in Period

   3. achievements

      1. comment

         2 participants assigned to lenvatinib17mg/m\^2 actually received 11mg/m\^2 (dose capped at 24 mg/day).

         group Id

         FG000

         num Subjects

         5

      2. comment

         2 participants assigned to lenvatinib17mg/m\^2 actually received 14mg/m\^2 (dose capped at 24 mg/day).

         group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         31

      6. comment

         4 participants assigned to lenvatinib14mg/m\^2 actually received 11mg/m\^2 (dose capped at 24 mg/day).

         group Id

         FG005

         num Subjects

         11

      7. group Id

         FG006

         num Subjects

         11

      8. group Id

         FG007

         num Subjects

         20

      type

      Treated (Safety Population)

   4. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         5

      8. group Id

         FG007

         num Subjects

         4

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         29

      6. group Id

         FG005

         num Subjects

         7

      7. group Id

         FG006

         num Subjects

         10

      8. group Id

         FG007

         num Subjects

         16

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Prior to entering Cohort 1, some participants aged 2 to less than (\<) 6 years underwent a run-in period and received lenvatinib 5 milligram per square meter (mg/m\^2) per body surface area (BSA) as capsules or suspension once daily for 21 days.

recruitment Details

Participants took part at 19 investigative sites in France, Germany, Italy, Spain, United Kingdom and the United States. Total 117 participants were enrolled and screened, of which 20 participants were screen failures and 97 participants received study treatment.

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Preserved source evidence · Not medical advice