Advanced Solid TumorsPhase 1NCT02354898
A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma
A Phase 1 study testing BBI503 and Sorafenib in people with Advanced Solid Tumors and Hepatocellular Carcinoma, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumors, Hepatocellular Carcinoma
- What is being tested?
- BBI503 and Sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2015to Oct 2018
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Advanced Solid Tumors, Hepatocellular Carcinoma
- Being tested
- BBI503, 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.
BBI503Drug
SorafenibDrug
Sorafenib 400mg twice daily (800mg total daily dose)
| Study group | Role | What they receive |
|---|---|---|
| BBI503, BBI503 and Sorafenib | Experimental | Not described Receives: Drug: BBI503; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine of the Maximum Tolerated Dose (MTD) of BBI503 monotherapy and in combination with Sorafenib by assessing dose-limiting toxicities (DLTs)
Measured: 36 days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Approximately 7 months
Pharmacokinetic profile of BBI503
Measured: 37 days
Secondary outcomes (3)
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
Measured: 6 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: Approximately1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354898
- Sponsor's protocol ID
- DA101003
- Status last verified
- Apr 2022
- First submitted
- 21 Jan 2015
- Last updated
- 12 Apr 2022
- Results posted
- No
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 BBI503 Monotherapy in Patients With Advanced Solid Tumors, or BBI503 Plus Sorafenib Combination Therapy in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02354898
- Acronym / sponsor ID
- DA101003
- Conditions
- Advanced Solid Tumors, Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 3 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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BBI503, BBI503 and Sorafenib | Experimental | Drug: BBI503, Drug: Sorafenib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| BBI503 | Drug | BBI503, BBI503 and Sorafenib |
| SorafenibSorafenib 400mg twice daily (800mg total daily dose) | Drug | BBI503, BBI503 and Sorafenib |
Primary outcome
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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Approximately 7 months
Pharmacokinetic profile of BBI503
Time frame: 37 days
3 secondary outcomes
Assessment of the preliminary anti-tumor activity by performing tumor assessments approximately every 8 weeks
Time frame: 6 months
Progression Free Survival
Time frame: Approximately 7 month
Overall Survival
Time frame: Approximately1 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BBI503 and Sorafenib in people with Advanced Solid Tumors and 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 8 inclusion and 7 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?
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). 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?
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; AzTrials last refreshed its copy on 6 Nov 2026.