Clinical trial · Interventional
Study of Eribulin in Children With Cancer to Determine Safety
A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Competing study opened
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin mesylate | Drug | Eribulin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eribulin
- description
- All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.
- interventionNames
- Drug: Eribulin mesylate
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- 1 year
- description
- The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
Secondary outcomes (3)
- measure
- Pharmacokinetics of eribulin in children with cancer
- timeFrame
- 8 days after first dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available