This is a Phase 1 Study of Eribulin Mesylate in Pediatric Patients With Recurrent or Refractory Solid Tumors (Excluding CNS), Including Lymphomas.

Phase 1

Conditions: Solid Tumors including Lymphomas
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-001894-34-Outside-EU/EEA

Lead Sponsor: Eisai Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 23

Inclusion Criteria

-Participants must be greater than or equal to 12 months and less than 18 years of age at the time of study enrollment.
-Participants must be greater than 6 months and less than 12 months of age at the time of study enrollment. Participants will enroll one dose level behind the dose level at which Participants in Part A1 are enrolling.
-Participants with refractory or recurrent solid tumors or lymphomas, excluding CNS tumors, are eligible. Participants must have had histologic -verification of malignancy at original diagnosis or relapse. Participants with primary CNS tumors, known CNS metastases, or a prior history of CNS metastases are not eligible.
-Participants must have either measurable or evaluable disease.
-Participant's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
Note: the list is not exhaustive.

Are the trial subjects under 18? yes
Number of subjects for this age range: 23
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective double barrier contraceptive method for the entire period in which they are receiving protocol therapy.
-Participants receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible.
-Participants who are currently receiving another investigational drug are not eligible.
-Participants who are currently receiving other anticancer agents are not eligible.
-Participants who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial.
Note: the list is not exhaustive.