Study of Eribulin in Children With Cancer to Determine Safety (ERIBULIN)

March 6, 2020 updated by: University of Oklahoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Jimmy Everest Center for Cancer and Blood Disorders in Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eribulin
All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.
Drug: Eribulin mesylate
Other Names:
  • Halaven

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose
Time Frame: 1 year
The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of eribulin in children with cancer
Time Frame: 8 days after first dose
13 blood samples will be drawn from each subject over first 8 days of protocol to measure serum levels of the agent eribulin.
8 days after first dose
Tumor expression of BRCP and ABCB1
Time Frame: 1 year
Archival tumor samples from each subject will be stained for expression of BRCP and ABCB1, transporter proteins responsible for some resistance to chemotherapy. Will compare expression and response data
1 year
Tumor response
Time Frame: 2 years
Subjects receiving eribulin will have scans approximately every 6 weeks to assess whether the tumors are growing, shrinking, or remaining stable.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Rene Y McNall-Knapp, MD, University of Oklahoma
  • Principal Investigator: Amanda Linz, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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