A Phase 1/2 single-arm study evaluating the safety and efficacy of eribulin mesilate in combination with irinotecan in children with refractory or recurrent solid tumors

Eisai Ltd0 sites88 target enrollmentStarted: June 29, 2018Last updated: August 31, 2020

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor
Enrollment: 88

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. a) Age: =12 months to =25 years old at the time of consent (no more than 25% of subjects between the ages of 18 and 25 years will be enrolled in this study). b) >6 months and <12 months at the times of consent (Phase 1 and Schedule A only) subjects will be enrolled one dose level behind he dose level at which the =12 months to <18 years old group are enrolled.
•2. Diagnosis:
•Phase 1: Histologically confirmed solid tumor, excluding CNS tumor, which is relapsed or refractory, and for which there are no currently available therapies.
•Phase 2: Histologically confirmed RMS, NRSTS or EWS which is relapsed or refractory having received at least 1 prior therapy), including primary treatment.
•3. Disease status:
•Phase 1: Subjects must have either measurable or evaluable disease as per RECIST 1.1.
•Phase 2: Subjects must have measurable disease as per RECIST 1.1.
•Measurable disease is defined as meeting the following criteria:
•a. At least 1 lesion of =1.0 cm in the longest diameter for a non-lymph node or =1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1 using computed tomography/magnetic resonance imaging (CT/MRI).
•b. Lesions that have had radiotherapy must show subsequent radiographic evidence of increase in size by at least 20% to be deemed a target lesion.
•4. Therapeutic options: Subject’s current disease state must be one for which there is no known curative therapy.
•5. Performance level: Performance score =50% Karnofsky (for subjects >16 years of age) or Lansky (for subjects =16 years of age).
•6. Subjects must have fully recovered from the acute toxic effects of all prior anticancer treatments prior to study drug administration:
•Myelosuppressive chemotherapy: Must not have received within 21 days to study drug administration (42 days if prior nitrosourea).
•Hematopoietic growth factors: Must not have received a long-acting growth factor (eg, Neulasta) within 14 days or a short-acting factor within 7 days. For agents that have known AEs occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor.
•Targeted therapy (antineoplastic agent eg, tyrosine kinase inhibitor): Must not have received an antineoplastic targeted therapy within 14 days. For agents that have known AEs occurring beyond 14 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor.
•Immunotherapy: Must not have received immunotherapy, e.g. tumor vaccines, within 42 days.
•Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.
•Radiotherapy (XRT): Must not have received within 14 days prior to study drug administration (small field) or 42 days for craniospinal XRT, or if =50% radiation of pelvis.
•Autologous Stem cell infusion: At least 84 days must have elapsed after stem cell infusion prior to study drug administration.
•Allogeneic bone marrow transplant, including mini-transplant: No evidence of active Graft vs. Host disease and at least 100 days must have elapsed after transplant or stem cell infusion prior to study drug administration.
•7. Adequate bone marrow function, defined as:
•Peripheral absolute neutrophil count (ANC) =1 × 109/L.
•Platelet count =100 × 109/L (transf

Exclusion Criteria

•1. Pregnancy, breastfeeding, contraception: Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic [ß-hCG] (or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
•- Females of childbearing potential* who:
•? Do not agree to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation, ie:
•? Total abstinence (if it is their preferred and usual lifestyle)
•? An intrauterine device (IUD) or intrauterine system (IUS)
•? A contraceptive implant
•? an oral contraceptive** OR
•? Do not have a vasectomized partner with confirmed azoospermia.
•*All post pubertal females will be considered to be of childbearing potential unless they have early menopause (amenorrheic for at least 12 consecutive months, in the
•appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral
•oophorectomy, all with surgery at least 1 month before dosing).
•**Must be on a stable dose of the same oral hormonal contraceptive product for at least 4 weeks before dosing with study drug and for the duration of the study and for 6 months after study drug discontinuation.
•2. Concomitant Medications:
•? Corticosteroids: Subjects receiving corticosteroids who have not been on a stable dose for at least 7 days prior to study drug administration.
•? Anticancer agents: Subjects who are currently receiving other anticancer agents.
•? Anti-GVHD agents post-transplant: Subjects who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant.
•? Strong CYP3A4 inducers/inhibitors, including traditional medicinal products (eg. St. John's Wort).
•3.Prior Therapies:
•? Phase 1: Received prior therapy with eribulin mesilate within 6 months prior to study drug administration.
•? Phase 2: Received prior therapies with eribulin mesilate or irinotecan
•hydrochloride (IH) (for prior IH subjects can be included if there was no tumor progression during IH therapy).
•4.Any malignancy that required treatment (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ), within 2 years prior to study drug administration.
•5.Has hypersensitivity to either study drug or any of the excipients.
•6.Has a known prior history* of viral hepatitis (B or C) as demonstrated by positive
•serology (presence of antigens) or have an uncontrolled infection requiring treatment (*
•Subjects with a known prior history of hepatitis B or C may be eligible pending
•agreement with the sponsor).
•7.Has > Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified (Balis”) Pediatric Scale of Peripheral Neuropathies.
•8.Has cardiac pathology, defined as:
•? Subjects with known congestive heart failure, symptomatic or LV ejection fraction
•<50% or shortening fraction <27% and subjects with congenital long QT syndrome,
•bradyarrhythmias, or QTc >480 msec on at least 2 separate ECGs.
•9.Has CNS disease: Subjects with brain or subdural metastases are not eligible unless the metastases are asymptomatic and do not require treatment or

Investigators

Sponsor

Eisai Ltd

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