NCT02596503

A Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors

A Phase I/II Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 13 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This IND-exempt Phase I trial will establish the recommended Phase II (RP2D) dose of eribulin in combination with fixed doses of oral irinotecan in adolescents and young adults with relapsed or refractory solid tumors. Eribulin will be administered intravenously on days 1 and 8 of a 21-day cycle, while irinotecan will be administered orally on days 1-5. Patients will be assigned an eribulin dose level at the time of enrollment using a 3+3 Phase I design, and there will be no intrapatient dose escalation. Once the RP2D has been established, there will be up to 10 patients enrolled in a dose expansion cohort. In absence of disease progression or toxicity, subjects may receive up to 17 cycles of therapy.

Conditions

• Relapsed Solid Tumors
• Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	Eribulin	Intravenous eribulin administered on days 1 and 8 of a 21-day cycle.
DRUG	Irinotecan	Irinotecan will be administered orally at a fixed dose of 90 mg/m2/day on days 1 -5 of a 21-day cycle.
OTHER	Cefixime	Cefixime will be given to all patients to reduce irinotecan-associated diarrhea. It will be administered Day -1 through Day 8 of each cycle.

Timeline

• Start date: 2015-10-21
• Primary completion: 2019-04-01
• Completion: 2020-01-24
• First posted: 2015-11-04
• Last updated: 2022-02-15

Locations

3 sites across 1 country: United States