A Phase 1/2 single-arm study evaluating the safety and efficacy of eribulin mesilate in combination with irinotecan in children with refractory or recurrent solid tumors

Eisai Ltd0 sites40 target enrollmentJuly 30, 2018

Overview

No summary available.

Registry

who.int

Start Date

July 30, 2018

End Date

May 17, 2021

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Eisai Ltd

•1\. Age: \=12 months to \<18 years old at the time of consent. \>6 months and \<12 months at the times of consent (Phase 1 and Schedule A only) subjects will be enrolled one dose level behind he dose level at which the \=12 months to \<18 years old group are enrolled.
•2\. Diagnosis:
•Phase 1: Histologically confirmed solid tumor, excluding CNS tumor, which is relapsed or refractory, and for which there are no currently available therapies.
•Phase 2: Histologically confirmed RMS, NRSTS or EWS which is relapsed or refractory having received at least 1 prior therapy), including primary treatment.
•3\. Disease status:
•Phase 1: Subjects must have either measurable or evaluable disease as per RECIST 1\.1\.
•Phase 2: Subjects must have measurable disease as per RECIST 1\.1\.
•Measurable disease is defined as meeting the following criteria:
•a. At least 1 lesion of \=1\.0 cm in the longest diameter for a non\-lymph node or \=1\.5 cm in the short\-axis diameter for a lymph node that is serially measurable according to RECIST 1\.1 using computed tomography/magnetic resonance imaging (CT/MRI).
•b. Lesions that have had radiotherapy must show subsequent radiographic evidence of increase in size by at least 20% to be deemed a target lesion.

•1\. Pregnancy, breastfeeding, contraception: Females who are breastfeeding or pregnant at Screening A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
•\- Females of childbearing potential\* who:
•? Do not agree to use a highly effective method of contraception for the entire study
•period and for 6 months after study drug discontinuation, ie:
•? Total abstinence (if it is their preferred and usual lifestyle)
•? An intrauterine device (IUD) or intrauterine system (IUS)
•? A contraceptive implant
•? an oral contraceptive\*\*
•? Do not have a vasectomized partner with confirmed azoospermia.
•\*All post pubertal females will be considered to be of childbearing potential unless they