A Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma

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

A Phase I Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma

This is an open-label, multicenter, phase 1 study of BBI608 in combination with Sorafenib. This study population is adult Japanese patients with advanced hepatocellular carcinoma in Sorafenib combination therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Tokyo,etc, Japan
        • 4 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or diagnosed imaging with hepatocellular carcinoma, and not indicated with a)-d) .

    1. Radiofrequency ablation therapy (RFA)
    2. Local therapy [such as percutaneous transhepatic ethanol injection therapy (PEIT), Microwave coagulation therapy (MCT)]
    3. Transcatheter arterial embolization (TAE)
    4. Transcatheter arterial chemoembolization (TACE)
  • ≥ 20 years of age.
  • Not treatment with systemic chemotherapy.
  • Signed written informed consent must be obtained and documented.
  • Life expectancy ≥ 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Must be Child Pugh Class A.
  • Hemoglobin ≥ 8.5 mg/dl.
  • Absolute neutrophil count ≥ 1.5 x 10^9 /L.
  • Platelets ≥ 75 x 10^9/L.
  • Creatinine ≤ 1.5 x ULN.
  • Total Bilirubin ≤ 3.0 mg/dl.
  • Aspartate Aminotransferase (AST) and Alanine transaminase (ALT) ≤ 5.0 x the upper limit of normal (ULN).
  • Females of childbearing potential must have a negative serum pregnancy test.
  • 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 BBI608 dose.

Exclusion Criteria:

  • Have had any t a)-i) treatment less than 28 days prior to beginning the enrolment.

    1. Radiation therapy
    2. Hormone therapy
    3. Immune therapy
    4. Hyperthermia
    5. Surgical procedure
    6. Local therapy (such as RFA, PEIT, MCT)
    7. TAE
    8. TACE
    9. other anti- tumour treatment
  • Have had a brain metastases with a symptom or requiring treatment.
  • Have had coinstantaneous active multiple cancers.
  • Have had a carcinomatous pleural effusion, ascites, or cardiac effusion requiring treatment.
  • Esophageal varix requiring treatment.
  • Patient of pregnancy or possibility of pregnancy, and planning breastfeeding by the end of BBI608 administration after 30days.
  • Crohns disease, ulcerative colitis, or historical surgery of extensively small intestine resection.
  • Unable or unwilling to swallow BBI608 capsules or Sorafenib tablets.
  • Uncontrolled inter-current illness (such as Grade 3active infection, or serious respiratory disease).
  • HIV infection.
  • Abnormal ECGs which are clinically significant within 28 days before enrolment.
  • Patients who are New York Heart Association (NYHA) functional classes III, or IV, or unstable angina.
  • Patients newly expressing angina within three months before the enrolment.
  • Have had myocardial infarction within six months before the enrolment.
  • Administrating with antiarrhythmic drug.
  • Have received other investigational products or post-marketing investigational products within 4 weeks of the first dose of BBI608.
  • Prior treatment with BBI608.
  • Hypersensitivity to Sorafenib or any other component of Sorafenib.
  • Ineligible for participation in the study in the opinion of the Investigators.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BBI608 puls Sorafenib
Drug: BBI608
Administered continuously twice daily with doses separated by 9-15 hours.
Drug: Sorafenib
Sorafenib 400 mg twice daily (800 mg total daily dose).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Assessment of safety and tolerability of BBI608 given in combination with Sorafenib by reporting of adverse events and serious adverse events.
Time Frame: 7 month
7 month
Assessment of dose-limiting toxicities (DLTs).
Time Frame: 29 days
29 days
Pharmacokinetic profile of BBI608 when administered in combination with Sorafenib.
Time Frame: On day 1: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose. On day 29: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose.
On day 1: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose. On day 29: Prior to BBI608 dosing and 2,4,6,8,10,12 and 24 hours after the first dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Assessment of the preliminary anti-tumour activity.
Time Frame: Approximately 7 months
Anti-tumour activity is assessed every 8 weeks from the first dose of BBI608 after the last dose of BBI608.The radiologic assessments will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and modified RECIST for patients with hepatocellular carcinoma.
Approximately 7 months
Overall Survival
Time Frame: Approximately 1 year
Participants follow-up for overall survival will occur. Maximum follow-up time is 1 year after the initial administration of the last subject.
Approximately 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8808001

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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