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

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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