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

April 9, 2022 updated by: Sumitomo Pharma Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Etc., Japan
        • 5 Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BBI503, BBI503 and Sorafenib
Drug: BBI503
Drug: Sorafenib
Sorafenib 400mg twice daily (800mg total daily dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
36 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Approximately 7 months
Approximately 7 months
Pharmacokinetic profile of BBI503
Time Frame: 37 days
37 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the preliminary anti-tumor activity by performing tumor assessments approximately every 8 weeks
Time Frame: 6 months
The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
6 months
Progression Free Survival
Time Frame: Approximately 7 month
The time the participant stays on study until progression will be measured and recorded.
Approximately 7 month
Overall Survival
Time Frame: 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.
Approximately1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA101003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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