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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354898
• Other study ID #: DA101003
• Status: Completed
• Phase: Phase 1
• Start date: March 2015
• Est. completion date: October 2018

Study information

• Verified date: April 2022
• Source: Sumitomo Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• BBI503

• Sorafenib
Sorafenib 400mg twice daily (800mg total daily dose)

Locations

Country	Name	City	State
Japan	5 Sites	Chiba, Etc.

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs)		36 days
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Approximately 7 months
Primary	Pharmacokinetic profile of BBI503		37 days
Secondary	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	6 months
Secondary	Progression Free Survival	The time the participant stays on study until progression will be measured and recorded.	Approximately 7 month
Secondary	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.	Approximately1 year