NCT03245151 · FLOW

Participant flow

Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors · Source last updated 2023-08-30

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

groups

description
Participants with recurrent or refractory solid tumors received lenvatinib 8 milligram per square meter (mg/m\^2), capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of disease progression (PD), clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
id
FG000
title
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2
description
Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
id
FG001
title
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2
description
Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
id
FG002
title
Phase 2: Cohort 1, Ewing Sarcoma
description
Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
id
FG003
title
Phase 2: Cohort 2, Rhabdomyosarcoma
description
Participants with recurrent or refractory high grade glioma (HGG) received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
id
FG004
title
Phase 2: Cohort 3, HGG

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
2
group Id
FG004
num Subjects
1
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
14
group Id
FG002
num Subjects
9
group Id
FG003
num Subjects
16
group Id
FG004
num Subjects
7
type
Death
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
group Id
FG002
num Subjects
0
group Id
FG003
num Subjects
0
group Id
FG004
num Subjects
0
type
Sponsor's decision
milestones
achievements
group Id
FG000
num Subjects
5
group Id
FG001
num Subjects
18
group Id
FG002
num Subjects
10
group Id
FG003
num Subjects
20
group Id
FG004
num Subjects
11
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
1
group Id
FG003
num Subjects
2
group Id
FG004
num Subjects
3
type
COMPLETED
achievements
group Id
FG000
num Subjects
5
group Id
FG001
num Subjects
15
group Id
FG002
num Subjects
9
group Id
FG003
num Subjects
18
group Id
FG004
num Subjects
8
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

A total of 86 participants were screened, out of which 64 were enrolled and 9 participants completed the study.

recruitment Details

Participants took part in the study at 24 investigative sites in the United States and Canada from 16 November 2017 to 30 September 2022.

Complete source fields