A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma
This is an open-label, multicenter, phase 1 dose escalation study of BBI503 monotherapy, or BBI503 in combination with Sorafenib. This study population is adult patients with advanced solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in combination therapy.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: BBI503, BBI503 and Sorafenib
Sorafenib 400mg twice daily (800mg total daily dose)
Primary Outcome Measures
- Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs) [36 days]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Approximately 7 months]
- Pharmacokinetic profile of BBI503 [37 days]
Secondary Outcome Measures
- Assessment of the preliminary anti-tumor activity by performing tumor assessments approximately every 8 weeks [6 months]
The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Progression Free Survival [Approximately 7 month]
The time the participant stays on study until progression will be measured and recorded.
- Overall Survival [Approximately1 year]
Participants follow-up for overall survival will occur. Maximum follow-up time is 1 year after the initial administration of the last subject.
Provision of written informed consent.
≥ 20 years of age
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
Females of childbearing potential must have a negative serum pregnancy test
Adequate organ function
Life expectancy ≥ 3 months
Any known symptomatic or untreated brain metastases
Pregnant or breastfeeding
Crohn's disease, ulcerative colitis extensive gastric and small intestine resection
Unable or unwilling to swallow BBI503 daily
Uncontrolled concurrent disease
Received other investigational drugs within 4 weeks prior to first dose
Prior treatment with BBI503
Contacts and Locations
|1||5 Sites||Chiba, Etc.||Japan|
Sponsors and Collaborators
- Sumitomo Pharma Co., Ltd.
Study Documents (Full-Text)None provided.