Colorectal CancerPhase 2NCT01776307
A Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
A Phase 2 study testing BBI608, Panitumumab and Capecitabine in people with Colorectal Cancer, run by Sumitomo Pharma America, Inc. at 13 sites in United States.
Trial summary
This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- BBI608, Panitumumab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2012to Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 colorectal cancer that is metastatic, unresectable, or recurrent.
- Patients must have received at least 2 regimens containing 5-Fluorouracil,oxaliplatin, or irinotecan.
- Patients to be enrolled in the Cetuximab or Panitumumab combination arms must have colorectal cancer which is K-Ras wild-type.
- ≥ 18 years of age.
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Show all 16Show fewer
- 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 BBI608 dose.
- Females of childbearing potential must have a negative serum pregnancy test.
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤1.5 × upper limit of normal(ULN), or ≤ 2.5 × ULN with metastatic liver disease.
- Hemoglobin (Hgb) ≥ 10 g/dl.
- Total bilirubin ≤ 1.5 × ULN.
- Creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
- Absolute neutrophil count ≥ 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 BBI608.
- Surgery within 4 weeks prior to first dose.
- Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases 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 and small intestine resection)
- Unable or unwilling to swallow BBI608 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
13 sites in 1 country.
13 sites in 1 country
United States13 sites
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
USOR - Texas Oncology Dallas
Dallas, Texas, 75246
USOR - Rocky Mountain Cancer Center
Denver, Colorado, 80218
USOR - Virginia Cancer Specialists
Fairfax, Virginia, 22031
Institute for Translational Oncology Research, Greenville Hospital System
Greenville, South Carolina, 29605
Mayo Clinic
Jacksonville, Florida, 32224
USOR - Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
USOR - Northwest Cancer Specialists
Portland, Oregon, 97227
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259
US Oncology Research
The Woodlands, Texas, 77380
USOR - Texas Oncology Tyler
Tyler, Texas, 75702
About this study
Official title: A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
This is an open label, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.
Read the detailed description
This is an open label, multi-center, Phase 2 study of BBI608 administered in combination with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and continuous oral administration of BBI608 for four weeks in combination with either cetuximab, or panitumumab, or capecitabine.
- Conditions
- Colorectal Cancer
- Being tested
- BBI608, Panitumumab, Capecitabine, Cetuximab
- Keywords
- BBI608
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI608Drug
Also called Napabucasin, BB608, BBI-608
BBI608 is administered at 500 mg po bid continuously.
PanitumumabDrug
Also called Vectibix
Panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.
CapecitabineDrug
Also called Xeloda
Capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.
CetuximabDrug
Also called Erbitux
Cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.
| Study group | Role | What they receive |
|---|---|---|
| BBI608 in combination with cetuximab | Experimental | Not described Receives: Drug: BBI608; Drug: Cetuximab |
| BBI608 in combination with panitumumab | Experimental | Not described Receives: Drug: BBI608; Drug: Panitumumab |
| BBI608 in combination with capecitabine | Experimental | Not described Receives: Drug: BBI608; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate
Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST 1.1, in patients with advanced colorectal cancer given napabucasin in combination with cetuximab, panitumumab or capecitabine
Measured: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months
Secondary outcomes (14)
Progression Free Survival
The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on Progression Free Survival (PFS) of patients with advanced colorectal cancer.
Measured: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months
Overall Survival
The effect of napabucasin given in combination with cetuximab, panitumumab or capecitabine on the Overall Survival of patients with advanced colorectal cancer
Measured: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months.
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 5 during the first study cycle
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 21 during the first study cycle
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 21 during the first study cycle
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 5 during the first study cycle
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the maximum concentration of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 21 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 5 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 480mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 21 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 240mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 21 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 5 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
To determine the area under the plasma concentration vs. time curve of napabucasin when given at 500mg, twice daily, in combination with cetuximab, panitumumab, or capecitabine in patients with advanced colorectal cancer.
Measured: Blood samples drawn on day 21 during the first study cycle
Pharmacodynamics
To determine the response (increase or decrease) of biomarkers from biopsied tumors following the administration of napabucasin
Measured: During the first 28 days of the study cycle
Number of Patients With Adverse Events and Serious Adverse Events
Assessment of safety of napabucasin given in combination with cetuximab, panitumumab or capecitabine to patients with advanced colorectal cancer by reporting of adverse events and serious adverse events
Measured: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2018
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William J. Edenfield, MD, Principal investigator, Institute for Translational Oncology Research, Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776307
- Sponsor's protocol ID
- BBI608-224
- Status last verified
- Nov 2023
- First submitted
- 21 Jan 2013
- Last updated
- 15 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01776307
- Acronym / sponsor ID
- BBI608-224
- Conditions
- Colorectal Cancer
- Keywords
- BBI608
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2018 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Posted 18 Jun 2021
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, multi-center, Phase 2 study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.
Detailed description
This is an open label, multi-center, Phase 2 study of BBI608 administered in combination with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and continuous oral administration of BBI608 for four weeks in combination with either cetuximab, or panitumumab, or capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BBI608 in combination with cetuximab | Experimental | Drug: BBI608, Drug: Cetuximab |
| BBI608 in combination with panitumumab | Experimental | Drug: BBI608, Drug: Panitumumab |
| BBI608 in combination with capecitabine | Experimental | Drug: BBI608, Drug: Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 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 colorectal cancer that is metastatic, unresectable, or recurrent.
- Patients must have received at least 2 regimens containing 5-Fluorouracil,oxaliplatin, or irinotecan.
- Patients to be enrolled in the Cetuximab or Panitumumab combination arms must have colorectal cancer which is K-Ras wild-type.
- ≥ 18 years of age.
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 BBI608.
- Surgery within 4 weeks prior to first dose.
- Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases 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 and small intestine 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 |
|---|---|---|
| BBI608Also: Napabucasin, BB608, BBI-608BBI608 is administered at 500 mg po bid continuously. | Drug | BBI608 in combination with capecitabine, BBI608 in combination with cetuximab, BBI608 in combination with panitumumab |
| PanitumumabAlso: VectibixPanitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes. | Drug | BBI608 in combination with panitumumab |
| CapecitabineAlso: XelodaCapecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks. | Drug | BBI608 in combination with capecitabine |
| CetuximabAlso: ErbituxCetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles. | Drug | BBI608 in combination with cetuximab |
Primary outcome
Disease Control Rate
Time frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months
Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST 1.1, in patients with advanced colorectal cancer given napabucasin in combination with cetuximab, panitumumab or capecitabine
14 secondary outcomes
Progression Free Survival
Time frame: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 24 months
Overall Survival
Time frame: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 60 months.
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
Time frame: Blood samples drawn on day 5 during the first study cycle
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
Time frame: Blood samples drawn on day 21 during the first study cycle
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
Time frame: Blood samples drawn on day 21 during the first study cycle
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
Time frame: Blood samples drawn on day 5 during the first study cycle
Determination of the Maximum Observed Concentration (Cmax) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
Time frame: Blood samples drawn on day 21 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 5 of the First Study Cycle
Time frame: Blood samples drawn on day 5 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 480mg, Twice Daily, on Day 21 of the First Study Cycle
Time frame: Blood samples drawn on day 21 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 240mg, Twice Daily, on Day 21 of the First Study Cycle
Time frame: Blood samples drawn on day 21 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 5 of the First Study Cycle
Time frame: Blood samples drawn on day 5 during the first study cycle
Area Under the Plasma Concentration vs. Time Curve (AUClast) of Napabucasin When Administered 500mg, Twice Daily, on Day 21 of the First Study Cycle
Time frame: Blood samples drawn on day 21 during the first study cycle
Pharmacodynamics
Time frame: During the first 28 days of the study cycle
Number of Patients With Adverse Events and Serious Adverse Events
Time frame: The time from the date of first treatment, while the patient is taking napabucasin, and for 30 days after stopping therapy, an average of 4 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William J. Edenfield, MD principal investigator
Institute for Translational Oncology Research, Greenville Hospital System
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BBI608, Panitumumab and Capecitabine in people with Colorectal Cancer, run by Sumitomo Pharma America, Inc. at 13 sites in United States.
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 16 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 15 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 13 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Control Rate (time frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 months). 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 15 Nov 2023.