Back to resultsA Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma
Primary Purpose
Advanced Solid Tumors, Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BBI503
Sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- 5 Sites
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BBI503, BBI503 and Sorafenib
Arm Description
Outcomes
Primary Outcome Measures
Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Pharmacokinetic profile of BBI503
Secondary Outcome Measures
Assessment of the preliminary anti-tumor activity by performing tumor assessments approximately every 8 weeks
The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Progression Free Survival
The time the participant stays on study until progression will be measured and recorded.
Overall Survival
Participants follow-up for overall survival will occur. Maximum follow-up time is 1 year after the initial administration of the last subject.
Full Information
NCT ID
NCT02354898
First Posted
January 21, 2015
Last Updated
April 9, 2022
Sponsor
Sumitomo Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02354898
Brief Title
A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma
Official Title
A Phase I Study of BBI503 Monotherapy in Patients With Advanced Solid Tumors, or BBI503 Plus Sorafenib Combination Therapy in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BBI503, BBI503 and Sorafenib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BBI503
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Sorafenib 400mg twice daily (800mg total daily dose)
Primary Outcome Measure Information:
Title
Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs)
Time Frame
36 days
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Approximately 7 months
Title
Pharmacokinetic profile of BBI503
Time Frame
37 days
Secondary Outcome Measure Information:
Title
Assessment of the preliminary anti-tumor activity by performing tumor assessments approximately every 8 weeks
Description
The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame
6 months
Title
Progression Free Survival
Description
The time the participant stays on study until progression will be measured and recorded.
Time Frame
Approximately 7 month
Title
Overall Survival
Description
Participants follow-up for overall survival will occur. Maximum follow-up time is 1 year after the initial administration of the last subject.
Time Frame
Approximately1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
5 Sites
City
Chiba, Etc.
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma
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