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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
240 mg twice daily (480 mg total daily dose)
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).
180 mg/m2 together with levofolinate will be administered intravenously per cycle(14 days).
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan
Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability]
Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs)
Time frame: 12 months
Number of participants with Dose-limiting toxicities (DLT) [Safety and Tolerability]
Safety and tolerability assessed by determination of unacceptable toxicity in patients.
Time frame: 12 months
Cmax (Peak plasma concentration)
Cmax (Peak plasma concentration)
Time frame: Day 1: prior to BBI608 and 2,4,6,8,10,12,24 hours after the first dose.
AUC0-24h (Area under the plasma concentration versus time curve)
AUC0-24h (Area under the plasma concentration versus time curve)
Time frame: Day 1: prior to BBI608 and 2,4,6,8,10,12,24 hours after the first dose.
Preliminary anti-tumour activity
The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST for patients with metastatic colorectal cancer.
Time frame: 6 months(an expected average)
Progression Free Survival (PFS)
Participants follow-up for progression free survival will occur. Maximum follow-up time is 12 months after the initial administration of the last subject.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
200 mg/m2 together with Irinotecan will be administered intravenously per cycle(14 days).
5 mg/kg will be administered intravenously following irinotecan/levofolinate infusion per cycle(14 days).