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 enrollmentJanuary 11, 2017

DrugsHalaven

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Eisai Ltd
Enrollment: 40
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 11, 2017

End Date

May 17, 2021

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eisai Ltd

Eligibility Criteria

Inclusion Criteria

•1\. a) Age: \=12 months to \=25 years old at the time of consent .b) In Phase 1, \>6 months and \<12 months at the time of consent (Schedule A only) subjects will be enrolled one dose level behind the \=12 months subjects. In Phase 2, subjects aged \>6 months and \<12 months at the time of consent will be enrolled to Schedule A with a modified dose of eribulin, Dose Level \-2 (0\.8 mg/m2 Day 1 and Day 8\) with the irinotecan dose maintained (40 mg/m2 Day 1 – Day 5\) of a 21\-day cycle.
•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
•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.
•4\. Therapeutic options: Subject's current disease state must be one for which there is no known curative therapy.

Exclusion Criteria

•1\.Pregnancy, breastfeeding, contraception: Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta\-human chorionic \[ß\-hCG] (or human chorionic gonadotropin \[hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß\-hCG \[or hCG]). 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 IUD or 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 have early menopause (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).