Cancer, Advanced Solid TumorsPhase 1NCT01781455
A Study of BBI503 in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing BBI503 in people with Cancer, Advanced Solid Tumors, run by Sumitomo Pharma America, Inc. at 19 sites in 2 countries.
Trial summary
This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advanced Solid Tumors
- What is being tested?
- BBI503
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Feb 2012to Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
- A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard curative or palliative therapies do not exist or are no longer effective.
- ≥ 18 years of age
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Karnofsky performance status ≥ 70%
- 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
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- Females of childbearing potential must have a negative serum pregnancy test
- Aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 1.5 × upper limit of normal (ULN)
- Hemoglobin (Hgb) ≥ 10 g/dl
- Total bilirubin < or equal to 1.5 × ULN
- Creatinine < or equal to 1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Absolute neutrophil count < or equal to 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Life expectancy ≥ 3 months
Who cannot join
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI503
- Surgery within 4 weeks prior to first dose
- Any known untreated brain metastases. Treated subjects must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
- Pregnant or breastfeeding
- Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection and small intestinal resection)
- Unable or unwilling to swallow BBI503 capsules daily
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Virginia Cancer Specialists, P.C.
Fairfax, Virginia, 22031
Texas Oncology- Fort Worth
Fort Worth, Texas, 76104
Institute for Translational Oncology Research, Greenville Hospital System
Greenville, South Carolina, 29605
Indiana University
Indianapolis, Indiana, 46202
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Virginia Oncology Associates
Norfolk, Virginia, 23502
Mayo Clinic Cancer Center, Rochester
Rochester, Minnesota, 55905
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
Cancer Care Centers of South Texas - HOAST
San Antonio, Texas, 78229
Mayo Clinic Cancer Center, Scottsdale
Scottsdale, Arizona, 85259
Texas Oncology- Tyler
Tyler, Texas, 75702
Yakima Memorial Hostpial/North Star Lodge
Yakima, Washington, 98902
About this study
Official title: A Phase I Clinical Study of BBI503 in Adult Patients With Advanced Solid Tumors
This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.
- Conditions
- Cancer, Advanced Solid Tumors
- Being tested
- BBI503
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI503Drug
| Study group | Role | What they receive |
|---|---|---|
| BBI503 | Experimental | Not described Receives: Drug: BBI503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Assessment of safety of BBI503 by reporting of adverse events and serious adverse events.
Measured: Adverse events will be assessed at baseline, while the participant is taking BBI503, and for 30 days after stopping therapy. The average length of this duration is expected to be approximately 4 months.
Determination of the recommended Phase 2 dose
Measured: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks
Secondary outcomes (3)
Pharmacokinetic profile (Area under the curve) of BBI503
Blood sampling to assess the pharmacokinetic profile (Area under the curve) of BBI503.
Measured: During the first 28 days of treatment
Pharmacodynamic activity
Tumor Biopsy(s) to provide information on analysis of the targets and downstream genes/ effect of BBI503 on cancer stem cells through immunohistochemistry.
Measured: During the first 28 days of treatment
Anti-tumor activity
To assess the preliminary anti-tumor activity of BBI503.
Measured: Participants will be assessed every eight weeks for anti-tumor activity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startFeb 2012
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, 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
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781455
- Sponsor's protocol ID
- BBI503-101
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2013
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of BBI503 in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01781455
- Acronym / sponsor ID
- BBI503-101
- Conditions
- Cancer, Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 1 Feb 2013 (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, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BBI503 | Experimental | Drug: BBI503 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
- A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard curative or palliative therapies do not exist or are no longer effective.
- ≥ 18 years of age
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Karnofsky performance status ≥ 70%
Key exclusion criteria (7 listed)
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI503
- Surgery within 4 weeks prior to first dose
- Any known untreated brain metastases. Treated subjects must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
- Pregnant or breastfeeding
- Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection and small intestinal resection)
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 |
Primary outcome
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Adverse events will be assessed at baseline, while the participant is taking BBI503, and for 30 days after stopping therapy. The average length of this duration is expected to be approximately 4 months.
Assessment of safety of BBI503 by reporting of adverse events and serious adverse events.
Determination of the recommended Phase 2 dose
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 weeks
3 secondary outcomes
Pharmacokinetic profile (Area under the curve) of BBI503
Time frame: During the first 28 days of treatment
Pharmacodynamic activity
Time frame: During the first 28 days of treatment
Anti-tumor activity
Time frame: Participants will be assessed every eight weeks for anti-tumor activity.
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 14 Nov 2023.
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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.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBI503 in people with Cancer, Advanced Solid Tumors, run by Sumitomo Pharma America, Inc. at 19 sites in 2 countries.
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 14 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. 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?
Number of participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Adverse events will be assessed at baseline, while the participant is taking BBI503, and for 30 days after stopping therapy. The average length of this duration is expected to be approximately 4 months.). The study lists 2 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 14 Nov 2023.