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 - NA

EISAI LIMITED0 sites111 target enrollmentJanuary 22, 2021

DrugsHalaven

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: EISAI LIMITED
Enrollment: 111
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 22, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

EISAI LIMITED

Eligibility Criteria

Inclusion Criteria

•1\. Age: \=12 months to \<18 years old at the time of ICF. \>6 months and \<12 months at the times of ICF pts will be enrolled one dose level behind he dose level at which the \=12 months to \<18 years old group are enrolled.2\. Diagnosis: Ph 1: Histologically confirmed solid tumor, excluding CNS tumor, which is relapsed or refractory, and for which there are no currently available therapies. Ph 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:Ph 1: Pts must have either measurable or evaluable disease as per RECIST 1\.1\. Ph 2: Pts 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 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: Pt’s current disease state must be one for which there is no known curative therapy.5\. Performance level: Performance score \=50% KPS or Lansky.6\. Pts must have fully recovered from the acute toxic effects of all prior anticancer treatments prior to study drug admin:• Myelosuppressive chemotherapy: Must not have received within 21 days to study drug admin Hematopoietic growth factors: Must not have received a long\-acting growth factor within 14 days or a short\-acting factor within 7 days. For agents that have known AEs occurring beyond 7 days after admin, 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:Must not have received an antineoplastic targeted therapy within 14 days. For agents that have known AEs occurring beyond 14 days after admin, 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 Ab.• XRT: Must not have received within 14 days prior to study drug admin 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 admin. • 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 admin.7\. Adequate bone marrow function, defined as:• ANC \=1 × 109/L.• Platelet count \=100 × 109/L.• Hb at least 8\.0 g/dL at baseline As blood transfusions are permitted to meet the hemoglobin criteria, pts must not be known to be refractory to red blood cell or platelet transfusions. 8\. Adequate renal function, defined as:• A serum creatinine based on age/gender, derived from the Schwartz formula for estimating GFR. Refer to table in protocol.• GFR \=50ml/min/1\.73m2, based on a 12 or 24h urine creatinine collection. 9\. Adequate liver function, defined as:• Bilirubin (sum of conjugated \+ unconjugated) \=1\.5 times the ULN for age.• Alkaline phosphatase, ALT and AST \=3 × ULN, unless there ar

Exclusion Criteria

•1\. Pregnancy, breastfeeding, contraception: Females who are breastfeeding or pregnant at Screening or Baseline. 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 IUD or 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: Pt receiving corticosteroids who have not been on a stable dose for at least 7 days prior to study drug administration. Anticancer agents: Pt who are currently receiving other anticancer agents. Anti\-GVHD agents post\-transplant: Pt who are receiving cyclosporine, tacrolimus or other agents to prevent graft\-versus\-host disease post bone marrow transplant. Strong CYP3A4 inducers/inhibitors.