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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02082626
Recruitment Status : Terminated (Competing study opened)
First Posted : March 10, 2014
Last Update Posted : March 10, 2020
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Solid Tumors Lymphoma Drug: Eribulin mesylate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
Actual Study Start Date : February 1, 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

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 Name: Halaven

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02082626

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United States, Oklahoma
Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
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Principal Investigator: Rene Y McNall-Knapp, MD University of Oklahoma
Principal Investigator: Amanda Linz, MD University of Oklahoma
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Responsible Party: University of Oklahoma Identifier: NCT02082626    
Other Study ID Numbers: 3812
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Oklahoma:
Phase I
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases