A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT02641873
- Lead Sponsor
- Sumitomo Pharma Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
-
A histologically confirmed advanced unresectable, metastatic or recurrent colorectal carcinoma
-
Evaluable patient by RECISTversion 1.1
-
Stage IV
-
≥ 20 years of age
-
Life expectancy ≥ 3 months.
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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Patients with following organ function within 14 days before enrollment (on the basis of the most recent data during the period if multiple data are available)
- Hemoglobin (Hg) ≥ 9.0 g/dL
- Neutrophil count ≥ 1.5 x 103/μL
- Platelet count ≥ 10 x 104/μL
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × institutional upper limit of normal (ULN) [≤ 5 × ULN in presence of liver metastases ]
- Total bilirubin ≤ 1.5 × institutional ULN [≤ 2 × ULN in presence of liver metastases ]
- Creatinine ≤ 1.5 × institutional ULN
- Proteinuria by dipstick urine analysis ≤ 1+. [ UPCR (Urine Albumin-to-Creatinine Ratio) ≤ 1, or protein volume of 24-hour urine collection ≤ 1 g, in the case of patients with a 2+ urine dipstick reading]
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For female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose or 6 months after Bevacizumab treatment.. For male patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 90 days after the last protocol treatment dose or 6 months after Bevacizumab treatment
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Females of childbearing potential have a negative urine pregnancy test
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Patients who have provided written voluntary consent in person to participate in this study after fully receiving and understanding the information about this study, including study
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or hormone therapy, or heart therapy within 21 days of the first dose of BBI608
- Major surgery within 28 days prior to first dose
- Have had a brain metastases with a symptom or requiring treatment
- Have had coinstantaneously active multiple primary cancer
- Have had a carcinomatous pleural effusion, ascites, or cardiac effusion requiring treatment
- Crohn's disease, ulcerative colitis, small intestine resection, diarrhea (watery diarrhea), paralysis intestinal, Intestinal obstruction
- Gastrointestinal perforation, tracheo-oesophageal fistula, fistula
- Unable or unwilling to swallow BBI608 capsules
- Uncontrolled inter-current illness (such as Grade 3 active infection, or serious respiratory disease)
- Uncontrolled hypertension
- Patients with recent history of hemoptysis of more than 2.5 mL of red blood within 28days before the enrolment
- Abnormal ECGs which are clinically significant within 28 days before enrolment
- Patients who are New York Heart Association (NYHA) functional classes III, or IV, or unstable angina
- Patients newly expressing angina within three months (90 days) before the enrolment
- Have had myocardial infarction within six months (180 days)before the enrolment
- Administrating with antiarrhythmic drug
- Patients who are planning to breast-feeding by whichever 30 days after the last administration of BBI608 or by 6 months after the last administration of Bevacizumab
- Patients of pregnancy or possibility of pregnancy at current time or possibility of pregnancy within 6 months after the last administration of Bevacizumab
- Have received other investigational products or not finished the assessment in any clinical study within 28 days before enrollment
- Known severe hypersensitivity to 5-FU/ levofolinate/ irinotecan/Bevacizumab
- Administration of atazanavir sulfate
- Prior treatment with BBI608
- Ineligible for participation in the study in the opinion of the Investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BBI608 + FOLFIRI +Bevacizumab BBI608 - BBI608 + FOLFIRI +Bevacizumab Levofolinate - BBI608 + FOLFIRI +Bevacizumab Irinotecan - BBI608 + FOLFIRI +Bevacizumab Bevacizumab - BBI608 + FOLFIRI +Bevacizumab 5-FU -
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability] 12 months Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs)
Number of participants with Dose-limiting toxicities (DLT) [Safety and Tolerability] 12 months Safety and tolerability assessed by determination of unacceptable toxicity in patients.
Cmax (Peak plasma concentration) Day 1: prior to BBI608 and 2,4,6,8,10,12,24 hours after the first dose. Cmax (Peak plasma concentration)
AUC0-24h (Area under the plasma concentration versus time curve) 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)
- Secondary Outcome Measures
Name Time Method Preliminary anti-tumour activity 6 months(an expected average) 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.
Progression Free Survival (PFS) 12 months Participants follow-up for progression free survival will occur. Maximum follow-up time is 12 months after the initial administration of the last subject.
Trial Locations
- Locations (2)
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan