Hepatocellular CarcinomaPhase 1NCT02358395
A Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma
A Phase 1 study testing BBI608 and Sorafenib in people with Hepatocellular Carcinoma, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- BBI608 and Sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2015to Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or diagnosed imaging with hepatocellular carcinoma, and not indicated with a)-d) .
- Radiofrequency ablation therapy (RFA)
- Local therapy [such as percutaneous transhepatic ethanol injection therapy (PEIT), Microwave coagulation therapy (MCT)]
- Transcatheter arterial embolization (TAE)
- Transcatheter arterial chemoembolization (TACE)
- ≥ 20 years of age.
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- 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.
Who cannot join
- Have had any t a)-i) treatment less than 28 days prior to beginning the enrolment.
- Radiation therapy
- Hormone therapy
- Immune therapy
- Hyperthermia
- Surgical procedure
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- Local therapy (such as RFA, PEIT, MCT)
- TAE
- TACE
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- BBI608, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI608Drug
Administered continuously twice daily with doses separated by 9-15 hours.
SorafenibDrug
Sorafenib 400 mg twice daily (800 mg total daily dose).
| Study group | Role | What they receive |
|---|---|---|
| BBI608 puls Sorafenib | Experimental | Not described Receives: Drug: BBI608; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability of BBI608 given in combination with Sorafenib by reporting of adverse events and serious adverse events.
Measured: 7 month
Assessment of dose-limiting toxicities (DLTs).
Measured: 29 days
Pharmacokinetic profile of BBI608 when administered in combination with Sorafenib.
Measured: 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 outcomes (3)
Assessment of the preliminary anti-tumour activity.
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.
Measured: Approximately 7 months
Progression Free Survival
The time the participant stays on study until progression will be measured and recorded.
Measured: Approximately 7 month
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.
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Drug Development Division, Study director, Sumitomo Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358395
- Sponsor's protocol ID
- D8808001
- Status last verified
- Apr 2022
- First submitted
- 21 Jan 2015
- Last updated
- 12 Apr 2022
- Results posted
- No
Publications
Okusaka T, Morimoto M, Eguchi Y, Nakamura S, Iino S, Kageyama R. A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Napabucasin Combined with Sorafenib in Japanese Patients with Unresectable Hepatocellular Carcinoma. Drugs R D. 2023 Jun;23(2):99-107. doi: 10.1007/s40268-023-00416-8. Epub 2023 May 15.
PubMed 37188895
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02358395
- Acronym / sponsor ID
- D8808001
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BBI608 puls Sorafenib | Experimental | Drug: BBI608, Drug: Sorafenib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or diagnosed imaging with hepatocellular carcinoma, and not indicated with a)-d) .
- ≥ 20 years of age.
- Not treatment with systemic chemotherapy.
- Signed written informed consent must be obtained and documented.
- Life expectancy ≥ 3 months.
Key exclusion criteria (28 listed)
- Have had any t a)-i) treatment less than 28 days prior to beginning the enrolment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBI608Administered continuously twice daily with doses separated by 9-15 hours. | Drug | BBI608 puls Sorafenib |
| SorafenibSorafenib 400 mg twice daily (800 mg total daily dose). | Drug | BBI608 puls Sorafenib |
Primary outcome
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
Assessment of dose-limiting toxicities (DLTs).
Time frame: 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.
3 secondary outcomes
Assessment of the preliminary anti-tumour activity.
Time frame: Approximately 7 months
Progression Free Survival
Time frame: Approximately 7 month
Overall Survival
Time frame: Approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 37188895Okusaka T, Morimoto M, Eguchi Y, Nakamura S, Iino S, Kageyama R. A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Napabucasin Combined with Sorafenib in Japanese Patients with Unresectable Hepatocellular Carcinoma. Drugs R D. 2023 Jun;23(2):99-107. doi: 10.1007/s40268-023-00416-8. Epub 2023 May 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director, Drug Development Division study director
Sumitomo Pharma Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBI608 and Sorafenib in people with Hepatocellular Carcinoma, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.