A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer

Sponsor
Sumitomo Pharma Co., Ltd.
Study ID
NCT02641873
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BBI608 — DRUG
    240 mg twice daily (480 mg total daily dose)
  • 5-FU — DRUG
    400 mg/m2 bolus will be administered intravenously immediately following irinotecan/levofolinate infusion, followed by 1200 mg/m2/day (total 2400 mg/m2) continuous infusion per cycle(14 days).
  • Irinotecan — DRUG
    180 mg/m2 together with levofolinate will be administered intravenously per cycle(14 days).
  • Levofolinate — DRUG
    200 mg/m2 together with Irinotecan will be administered intravenously per cycle(14 days).
  • Bevacizumab — DRUG
    5 mg/kg will be administered intravenously following irinotecan/levofolinate infusion per cycle(14 days).

Study Details

This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI + Bavacizumab. This study population is adult Japanese patients with metastatic colorectal cancers in FOLFIRI + Bevacizumab combination therapy.

Key Dates

First listed
Dec 30, 2015
Start date
Dec 31, 2015
Status verified
Apr 2022
Primary completion
Dec 31, 2016
Completion
Jan 31, 2017

Study Design

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

Arms

  • Experimental: BBI608 + FOLFIRI +Bevacizumab

Primary Outcome Measure

Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability] [ Time Frame: 12 months ]

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