ADVL1722/Eisai E7389G000223: A Phase 2, multicenter, open-label study to assess safety and preliminary activity of eribulin mesylate in pediatric subjects with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) an

This study will be conducted as an assessment of the safety and preliminary activity of eribulin mesylate in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), or Ewing sarcoma (EWS) to determine whether each cohort warrants further investigation.

Principal Investigator:
Van Huynh, MD

Research Coordinator:
Tina Templeman, RN
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.



  • Clinical Trial Info
  • IRB Number: 1711135
  • Sponsor: Eisai
  • Protocol Number: ADVL1722
  • NCT Number: NCT03441360
  • Research Type: Adolescents and Young Adults, Recurrent/Refractory Cancer, Solid Tumors
  • Phase: I
  • Status: Active

Key Inclusion Criteria:

  • Age: ≥12 months to <18 years old at the time of informed consent
  • Diagnosis: Histologically confirmed rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) (Grade 2 or 3), or Ewing sarcoma (EWS) which is relapsed or refractory (failed front line therapy)
  • The presence of measurable disease.
  • Standard organ function requirements

Key Exclusion Criteria:

  • Has hypersensitivity to eribulin or any of the excipients
  • Has a prior history of viral hepatitis (B or C) as demonstrated by positive serology (presence of antigens) or have an uncontrolled infection requiring treatment.
  • Participants with a known prior history of hepatitis B or C may be eligible pending agreement with the sponsor
  • Has > Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy
  • Cardiac pathology: 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 QTc >480 msec 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 (eg, surgery or radiotherapy) and have discontinued the use of corticosteroids for this indication for at least 4 weeks 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.
  • 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 administrationLaparoscopic procedure or open biopsy within 7 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

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