This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas

Completed · Phase 1

Conditions studied: Pediatrics, Solid Tumors

In brief

This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims to determine the maximum tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of this regimen in Part A1 (participants greater than or equal to \[\>=\] 12 months and less than \[\<\] 18 years). Part A2 will enroll infants (greater than \[\>\] 6 months and \<12 months) one dose level behind the dose level at which participants in Part A1 are enrolling, in order to maximize safety for infant participants. Additionally, this study aims to describe the toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a preliminary manner, the antitumor effect of eribulin mesylate will also be described.

Key facts

Study ID: NCT02171260
Run by: Eisai Inc.
People needed: 23
Starts: 2014-07-31
Expected to finish: 2016-01-28
Last updated by the study team: 2019-01-15

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants must be >=12 months and <18 years of age at the time of study enrollment (Part A1).
Participants must be >6 months and <12 months of age at the time of study enrollment (Part A2). 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.
Participants 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.
Karnofsky >= 50% for participants >16 years of age and Lansky >=50 for participants less than or equal to (<=)16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Participants must have fully recovered from the acute toxic effects of all prior anticancer chemotherapy.
Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).
Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (example Neulasta) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
Biologic (anti-neoplastic agent): At least 14 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 14 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
Immunotherapy: At least 42 days after the completion of any type of immunotherapy, example tumor vaccines.
Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.
X-ray telescope (XRT): At least 14 days after local palliative XRT (small port); At least 150 days must have elapsed if prior total body irradiation(TBI), craniospinal and/or entire spinal XRT or if >=50% radiation of pelvis; At least 42 days must have elapsed if other substantial bone marrow (BM) radiation.
Stem Cell Infusion without TBI: No evidence of active graft versus host disease and at least 84 days must have elapsed after transplant or stem cell infusion.
Adequate Bone Marrow Function Defined as:
Peripheral absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm\^3).
Platelet count >=100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
Hemoglobin (Hb) at least 8 gram per deciliter (g/dL) at baseline (blood transfusions are allowed during the screening period to correct Hb values less than 8 g/dL).
All participants enrolled on the study must be evaluable for hematologic toxicity.
Adequate Renal Function Defined as:
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >=70 milliliter per minute (ml/min) per (/) 1.73 square meter (m\^2) or
A serum creatinine milligram per deciliter (mg/dL) based on age/gender as follows:
6 months to <1 year: male, 0.5; female, 0.5
1 to < 2 years: male, 0.6; female, 0.6
2 to < 6 years: male, 0.8; female, 0.8

You may not qualify if…

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 and up to 6 months after treatment.
Concomitant Medications
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.
Participants who are receiving drugs that prolong the QTc are not eligible.
Participants who have received prior therapy with eribulin mesylate are not eligible.
Participants with hypersensitivity to excipients of the study drug are not eligible. The excipients are ethanol, hydrochloric acid, sodium hydroxide and water for injection.
Participants who have a prior history of viral hepatitis (B or C) as demonstrated by positive serology (presence of antigens) or have an uncontrolled infection requiring treatment are not eligible.
Participants with greater than Grade 1 peripheral sensory neuropathy or greater than Grade 1 peripheral motor neuropathy graded according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies are not eligible.
Cardiac Pathology
Participants with known congestive heart failure, symptomatic or left ventricle (LV) ejection fraction 50% or shortening fraction less than 27% are not eligible.
Participants with congenital long QT syndrome, bradyarrhythmias, or QTc greater than 480 msec are not eligible.
CNS Disease
Participants with primary CNS tumors are not eligible.
Participants with prior history of or known metastatic CNS disease involvement are not eligible. (Note: CNS imaging for participants without a known history of CNS disease is only required if clinically indicated).
Participants who have had or are planning to have the following invasive procedures are not eligible:
Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment.
Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (with example, Hickman or Broviac) and at least 7 days prior to enrollment for subcutaneous port.
Core biopsy within 7 days prior to enrollment.
Fine needle aspirate within 7 days prior to enrollment. NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy.
Participants with known bone marrow involvement are not eligible.
Participants who have received a prior solid organ transplantation are not eligible.
Participants who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.

Where it is running

Children's Hospital of Alabama — Birmingham, Alabama, United States
Childrens Hospital of Orange County — Orange, California, United States
UCSF Medical Center-Parnassus — San Francisco, California, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
Riley Hospital for Children — Indianapolis, Indiana, United States
C S Mott Children's Hospital — Ann Arbor, Michigan, United States
University of Minnesota Cancer Center-Fairview — Minneapolis, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
Columbia University Medical Center — New York, New York, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Oregon Health and Science University — Portland, Oregon, United States
Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Baylor College of Medicine — Houston, Texas, United States
Seattle Children's Hospital — Seattle, Washington, United States
Midwest Children's Cancer Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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