NCT00866281 · FLOW

Participant flow

A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia · Source last updated 2015-12-22

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

groups

description
Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m\^2 twice daily (bid) through oral route. The total daily dose in 30 mg/m\^2 bid cohort was 60 mg/m\^2.
id
FG000
title
Cohort 1: Midostaurin (30 Milligrams/Meters^2)
description
Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m\^2 bid through oral route. The total daily dose in 60 mg/m\^2 bid cohort was 120 mg/m\^2.
id
FG001
title
Cohort 2: Midostaurin (60 mg/m^2)

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Adverse Event
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
0
type
Withdrawal by participants
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
11
type
Disease progression
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
4
type
New cancer therapy
milestones
achievements
group Id
FG000
num Subjects
7
group Id
FG001
num Subjects
15
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
7
group Id
FG001
num Subjects
15
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

A total of 22 participants were enrolled in the study.

recruitment Details

The study was conducted at 8 centers in 5 countries.

Complete source fields