Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors

  • STATUS
    Recruiting
  • End date
    Sep 30, 2021
  • participants needed
    111
  • sponsor
    Eisai Inc.
Updated on 25 January 2021
Investigator
Eisai Medical Information
Primary Contact
Royal Marsden Hospital - Surrey (0.0 mi away) Contact
+34 other location
platelet count
renal function
graft versus host disease
monoclonal antibodies
nitrosoureas
measurable disease
growth factor
stem cell infusion
glomerular filtration rate
schwartz
metastasis
neutrophil count
irinotecan
nitrosourea
cancer chemotherapy
antineoplastic
solid tumor
platelet transfusion
myelosuppressive chemotherapy
ewing's sarcoma
neulasta
nervous
cns tumor
tumor vaccines
cancer vaccine
soft tissue sarcoma

Summary

The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory solid tumors (excluding central nervous system [CNS] tumors).

The Phase 2 part of the study is conducted to assess the objective response rate (ORR) and duration of response (DOR) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and ewing sarcoma (EWS).

Details
Condition Ewing's sarcoma, Rhabdomyosarcoma, Refractory or Recurrent Solid Tumors, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma
Treatment irinotecan hydrochloride, Eribulin Mesilate
Clinical Study IdentifierNCT03245450
SponsorEisai Inc.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Phase 1: Participants must be diagnosed with histologically confirmed solid tumors (excluding CNS tumors), which is relapsed or refractory, and for which there are no currently available therapies
Phase 2: Participants must be diagnosed with histologically confirmed RMS, NRSTS or EWS which is relapsed or refractory having received at least 1 prior therapy, including primary treatment
Phase 1: Participants must have either measurable or evaluable disease as per RECIST 1.1
Phase 2: Participants must have measurable disease as per RECIST 1.1
Participant's current disease state must be one for which there is no known curative therapy
Participant's performance score must be >=50% Karnofsky (for participants >16 years of age) or Lansky (for participants <=16 years of age).Participants who are unable to walk because of paralysis and/or previous surgeries, but who are 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 treatments prior to study drug administration
Must not have received myelosuppressive chemotherapy within 21 days prior to study drug administration (42 days if prior nitrosourea)
Must not have received a long-acting growth factor (eg, Neulasta) within 14 days or a short-acting growth factor within 7 days
Must not have received an antineoplastic targeted therapy within 14 days
Must not have received immunotherapy, eg, tumor vaccines, within 42 days
Must not have received monoclonal antibodies within at least 3 half-lives of the antibody after its last dose
Must not have received radiotherapy (XRT) within 14 days prior to study drug administration (small field) or 42 days for craniospinal XRT, or if >=50% radiation of pelvis
At least 84 days must have elapsed after stem cell infusion prior to study drug administration
No evidence of active graft-versus-host disease (GVHD) and at least 100 days must have elapsed after allogeneic bone marrow transplant or stem cell infusion prior to study drug administration
Participants must have adequate bone marrow function, defined as
Peripheral absolute neutrophil count (ANC) >=1.010^9/liter (L)
Platelet count >=10010^9/L (not receiving platelet transfusions within a 7-day period prior to study drug administration)
Hemoglobin (Hb) at least 8.0 grams per deciliter (g/dL) at baseline (blood transfusions are allowed during the screening period to correct Hb values less than 8.0 g/dL)
Participants must have adequate renal function, defined as
A serum creatinine based on age/gender, derived from the Schwartz formula for estimating glomerular filtration rate (GFR), per protocol-specified criteria
Serum creatinine clearance or GFR >=50 milliliters/minute/1.73 m^2, based on a 12 or 24 hours (h) urine creatinine collection
Participants must have adequate liver function, defined as
Bilirubin (sum of conjugated + unconjugated) <=1.5 times the upper limit of normal (ULN) for age
Alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 _ULN (in the case of liver metastases <=5_ULN), unless there are bone metastases, in which case liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase
Serum albumin >=2 g/dL
All participants and/or their parents or guardians must sign a written informed consent
Participants must be willing to comply with all aspects of the protocol

Exclusion Criteria

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 h 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
Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period or for 3 months after study drug discontinuation). No sperm donation is allowed during the study period or for 3 months after study drug discontinuation
Concomitant Medications
Participants receiving corticosteroids who have not been on a stable dose for at least 7 days prior to study drug administration
Participants who are currently receiving other anticancer agents
Participants who are receiving cyclosporine, tacrolimus or other agents to prevent GVHD post bone marrow transplant
Participants who are receiving strong cytochrome P450 3A4 (CYP3A4) inhibitors and inducers including traditional herbal medicinal products (eg St. John's Wort)
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 (for prior irinotecan hydrochloride, participants can be included if there was no tumor progression during irinotecan therapy)
Any other malignancy that required treatment (except non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ), within 2 years prior to study drug administration
Has hypersensitivity to either study drug or any of the excipients
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
Has greater than Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies
Has cardiac pathology, defined as
Participants with known congestive heart failure, symptomatic or Left ventricular (LV) ejection fraction <50% or shortening fraction <27% and participants with congenital long QT syndrome, bradyarrhythmias, or QT interval (QTc)>480 milliseconds on at least 2 separate electrocardiograms (ECGs)
Has CNS disease: Participants with brain or subdural metastases are not eligible unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy and have discontinued the use of corticosteroids for this indication for at least 28 days prior to study drug administration. Participants must be clinically stable. It is not the intention of this protocol to treat participants with active brain metastases
Note: Screening CNS imaging for participants with a known history of CNS
disease is required
Have had or are planning to have the following invasive procedures
Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration
Laparoscopic procedure or open biopsy within 7 days prior to study drug administration
Central line placement or subcutaneous port placement is not considered major surgery
Core biopsy, including bone marrow biopsy within 2 days prior to study drug administration
Fine needle aspirate within 3 days prior to study drug administration
Participants with known human immunodeficiency virus (HIV); due to lack of available safety data for eribulin therapy in HIV infected participants
Has any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments (including active or severe chronic inflammatory bowel disease or bowel obstruction)
Has received a live-virus vaccination within 30 days of planned start of study therapy. Seasonal flu vaccines that do not contain live virus are permitted
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