EUCTR2016-003352-67-PL
Active, not recruiting
Phase 1
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 sites40 target enrollmentJanuary 17, 2020
ConditionsPhase 1: paediatric subjects with relapsed/refractory solid tumors (excluding CNS)Phase 2: paediatric subjects with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and Ewing sarcoma (EWS)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsHalaven
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Phase 1: paediatric subjects with relapsed/refractory solid tumors (excluding CNS)Phase 2: paediatric subjects with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and Ewing sarcoma (EWS)
- Sponsor
- Eisai Ltd
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 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) Phase 1,\>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:
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:
Outcomes
Primary Outcomes
Not specified
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