Study Stopped
Competing study opened
Study of Eribulin in Children With Cancer to Determine Safety
ERIBULIN
A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
March 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 10, 2020
March 1, 2020
4.3 years
March 6, 2014
March 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose
The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
1 year
Secondary Outcomes (3)
Pharmacokinetics of eribulin in children with cancer
8 days after first dose
Tumor expression of BRCP and ABCB1
1 year
Tumor response
2 years
Study Arms (1)
Eribulin
EXPERIMENTALAll patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma, 73104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rene Y McNall-Knapp, MD
University of Oklahoma
- PRINCIPAL INVESTIGATOR
Amanda Linz, MD
University of Oklahoma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2014
First Posted
March 10, 2014
Study Start
February 1, 2014
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
March 10, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share