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

NCT02641873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-04-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BBI608

240 mg twice daily (480 mg total daily dose)

DRUG

5-FU

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).

DRUG

Irinotecan

180 mg/m2 together with levofolinate will be administered intravenously per cycle(14 days).

DRUG

Levofolinate

200 mg/m2 together with Irinotecan will be administered intravenously per cycle(14 days).

DRUG

Bevacizumab

5 mg/kg will be administered intravenously following irinotecan/levofolinate infusion per cycle(14 days).

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Japan

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02641873 on ClinicalTrials.gov