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.|
|ClinicalTrials.gov Identifier: NCT02082626|
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Cancer Solid Tumors Lymphoma||Drug: Eribulin mesylate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.
Drug: Eribulin mesylate
Other Name: Halaven
- 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
- 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.
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02082626
|United States, Oklahoma|
|Jimmy Everest Center for Cancer and Blood Disorders in Children|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Rene Y McNall-Knapp, MD||University of Oklahoma|
|Principal Investigator:||Amanda Linz, MD||University of Oklahoma|