Participant flow

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma · Source last updated 2024-07-22

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

groups

1. description

   Participants received lenvatinib 14 milligrams per square meter (mg/m\^2), capsules, orally, once daily, plus ifosfamide 3000 milligrams per square meter per day (mg/m\^2/day), intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until disease progression (PD), development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.

   id

   FG000

   title

   Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide

2. description

   Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per response evaluation criteria in solid tumors (RECIST) version (v) 1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.

   id

   FG001

   title

   Treatment Arm B: Ifosfamide + Etoposide

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         10

      type

      Survival follow-up discontinued by sponsor

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Participants transitioned to patient access program (PAP)

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Participants transitioned to managed access program (MAP)

   5. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         25

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         41

      comment

      Participant Flow (including deaths in reasons of discontinuation) was based on Full Analysis Set (Full Analysis Set included all randomized participants regardless of the treatment actually received).

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         39

      type

      Treated (Safety Analysis Set)

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         16

      comment

      Participants from Treatment Arm B: Ifosfamide + Etoposide who had PD per RECIST v1.1 were eligible to receive an optional lenvatinib treatment plus any remaining cycles of chemotherapy (ifosfamide + etoposide) if 5 cycles were not completed prior to PD.

      type

      Optional Lenvatinib Treatment (Arm B Only)

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         41

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 99 participants were screened, 18 failed screening. 81 participants were enrolled and randomized, out of which 78 received the study treatment.

recruitment Details

Participants took part in the study at 84 investigative sites in Austria, Australia, Belgium, Hong Kong, Korea, New Zealand, Singapore, Taiwan, Czech Republic, Finland, France, Israel, Ireland, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, Canada, and the United States.

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Preserved source evidence · Not medical advice