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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT02596503
Phase
PHASE1
Status
Completed

Conditions

  • Refractory Solid Tumors
  • Relapsed Solid Tumors

Eligibility Criteria

Sex
ALL
Age
13 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 21, 2015
Status verified
Jan 2022
Primary completion
Apr 30, 2019
Completion
Jan 24, 2020

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Eribulin + Irinotecan
    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. The oral antibiotic cefixime will be used to reduce irinotecan-associated diarrhea. Eribulin dose will be assigned at time of enrollment using a 3+ 3 Phase 1 design (ranging from 0.8 - 1.4 mg/m2/dos). The dose of irinotecan will be fixed at 90 mg/m2/day x 5 days.

Primary Outcome Measure

The recommended Phase II dose of eribulin when used in combination with oral irinotecan [ Time Frame: Within 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045-
University of KentuckyLexingtonKentucky40536-
University of Texas, Southwestern Medical CenterDallasTexas--

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COUniversity of Kentucky· Lexington, KYUniversity of Texas, Southwestern Medical Center· Dallas, TX

Related Studies