Advanced Solid Tumors, Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGBBI503
DRUGSorafenib
Sorafenib 400mg twice daily (800mg total daily dose)
Sponsors
Sumitomo Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Outcome results
None listed