Eribulin mesilate with irinotecan in children with solid tumours

• Research type

  Research Study

• Full title

  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

• IRAS ID

  249639

• Contact name

  Lynley Marshall

• Contact email

  lynleyvanessa.marshall@icr.ac.uk

• Sponsor organisation

  Eisai Ltd.

• Eudract number

  2016-003352-67

• Clinicaltrials.gov Identifier

  NCT03245450

• Duration of Study in the UK

  2 years, 10 months, 30 days

• Research summary

  Eribulin mesilate is an anticancer chemotherapy authorised to treat adults with advanced or metastatic breast cancer and liposarcoma.

  Previous studies have shown eribulin has activity in soft tissue sarcoma and is tolerable in children. Combining irinotecan with eribulin may have more activity against Rhabdomyosarcoma (RMS), Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS) than when used alone.

  This study will evaluate the safety and efficacy of eribulin with irinotecan in children with solid tumours that have returned or are unresponsive to treatment. The study is divided into 2 phases.

  Phase 1 will determine the maximum tolerated dose of eribulin with irinotecan and includes 2 schedules (21-day cycles):
  Schedule A - eribulin Days 1 and 8 plus irinotecan Days 1-5
  Schedule B - eribulin Days 1 and 8 plus irinotecan Days 1 & 8

  Children under 12 months old will be enrolled onto Schedule A only, at a lower dose. 3 patients will initially be enrolled into each Schedule at the starting dose, with additional patients enrolled at the next dose level up or down, depending on the patients’ tolerability of the treatment. Up to 36 patients will be enrolled in Phase 1.

  Phase 2 will evaluate the safety and efficacy of eribulin with irinotecan. 9 patients will be enrolled into each of 3 tumour groups: RMS, NRSTS and EWS. A further 16 patients will be enrolled into each group if more than 2 responses are seen. Up to 75 patients will be enrolled in Phase 2.

  Patients can remain on treatment for up to 1 year if they are receiving benefit. Patients will be asked to attend regular clinic visits during treatment, with 2 further visits during follow up. Study procedures include physical and neurologic examinations, vital signs, ECGs, blood and urine tests, CT/MRI/bone scans.

  Sponsor is Eisai Ltd.

• REC name

  London - Central Research Ethics Committee

• REC reference

  18/LO/1937

• Date of REC Opinion

  7 Jan 2019

• REC opinion

  Further Information Favourable Opinion