Study of Eribulin in Children With Cancer to Determine Safety



Status:Completed
Conditions:Cancer, Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 20
Updated:2/28/2019
Start Date:February 1, 2014
End Date:June 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors

This is a study for children with cancer with no curative treatment options. The
investigators will be giving eribulin, a new chemotherapy agent, for the first time to
children. This study is designed to determine a safe dose the investigators can give to
children in larger studies. The investigators will be monitoring the children on this study
for the safety of the treatment and levels of eribulin in the blood after treatment. The
investigators will also study the effect of the agent on the cancer.

This is a phase I study of eribulin, a novel tubulin inhibitor in children with relapsed and
refractory solid tumors including lymphoma. Dose escalation will be performed in a classic
3+3 design starting with 75% of the adult maximum tolerated dose (MTD). Pharmacokinetics will
be done on each patient. Primary endpoint will be the pediatric MTD.

Inclusion Criteria:

- Age: ≤ 21 years of age at the time of study enrollment

- Diagnosis: refractory or recurrent solid tumors, including lymphomas, except those
with CNS tumors or known CNS metastases

- Disease Status: measurable or evaluable disease

- Adequate organ function as defined in protocol

Exclusion Criteria:

- Pregnant or breastfeeding
We found this trial at
1
site
Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma 73104
Phone: 405-271-4412
?
mi
from
Oklahoma City, OK
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