A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma
NCT ID: NCT02354898
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2015-03-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BBI503, BBI503 and Sorafenib
BBI503
Sorafenib
Sorafenib 400mg twice daily (800mg total daily dose)
Interventions
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BBI503
Sorafenib
Sorafenib 400mg twice daily (800mg total daily dose)
Eligibility Criteria
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Inclusion Criteria
* ≥ 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
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Sumitomo Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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5 Sites
Chiba, Etc., , Japan
Countries
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Other Identifiers
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DA101003
Identifier Type: -
Identifier Source: org_study_id
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