A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Hepatocellular Carcinoma
• Interventions: Drug: BBI503; Drug: Sorafenib

• Registration Number: NCT02354898
• Lead Sponsor: Sumitomo Pharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-03
• Study Start: 2015-03
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BBI503, BBI503 and Sorafenib	BBI503	-
BBI503, BBI503 and Sorafenib	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Progression Free Survival	Approximately 7 month	The time the participant stays on study until progression will be measured and recorded.
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
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.

Trial Locations

Locations (1)

5 Sites; 🇯🇵 Chiba, Etc., Japan