Hematologic MalignancyPhase 1NCT02352558
A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies
A Phase 1 study testing BBI608, Dexamethasone and Bortezomib in people with Hematologic Malignancy, run by Sumitomo Pharma America, Inc. at 8 sites in United States.
Trial summary
This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- BBI608, Dexamethasone and Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2015to 16 May 2019
- 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
Major Inclusion Criteria:
- Signed written informed consent must be obtained and documented according to the International Conference on Harmonisation (ICH) and be in accordance with local regulatory requirements
- A histologically confirmed hematologic malignancy that is advanced, relapsed, or refractory to standard, currently available anti-cancer treatment options
- ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at dose escalation phase and of ≤ 2 at dose expansion phase
- 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 their last dose
- Females of childbearing potential must have a negative serum pregnancy test
- Aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN). Patients whose disease involves the liver and who have laboratory values of AST ≤ 3.5 ULN, AST ≤ 3.5 ULN, and albumin ≥ 35g/L may be enrolled if agreed upon by the Principal Investigator and Medical Monitor for the Sponsor
- Total bilirubin < 1.5 x ULN, except for cases in which elevation of total bilirubin is due to elevated levels of unconjugated bilirubin consistent with a diagnosis of Gilbert's Syndrome
- Life expectancy ≥ 3 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Virginia Cancer Specialists, P.C.
Fairfax, Virginia, 22031
West Clinic
Germantown, Tennessee, 38138
Indiana University
Indianapolis, Indiana, 46202
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
Cancer Care Centers of South Texas - HOAST
San Antonio, Texas, 78229
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684
About this study
Official title: A Phase Ib Clinical Study of BBI608 for Adult Patients With Advanced, Refractory Hematologic Malignancies
This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.
- Conditions
- Hematologic Malignancy
- Being tested
- BBI608, Dexamethasone, Bortezomib, Imatinib, Ibrutinib
- Keywords
- Multiple Myeloma, Lymphoma, Acute Myeloid Leukemia, Myelo-Dysplastic Syndrome, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Medical subject headings
- Hematologic Neoplasms, Multiple Myeloma, Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell
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
Patients will receive BBI608 orally twice daily, with doses separated by approximately 12 hours. The starting dose for all cohorts will be 240 mg twice daily. Subsequently, cohorts at alternate dose-levels (480 mg twice daily) may be enrolled as determined by the criteria for dose-escalation.
DexamethasoneDrug
Dexamethasone will be taken orally at a dose level of 40 mg once weekly, on Days 1, 8, 15, and 22 of each Cycle. Patients over the age of 75 years are allowed to begin dexamethasone at a dose of 20 mg once weekly, on Days 1, 8, 15, and 22 of each Cycle. Dexamethasone should be taken with food or milk, and a minimum of 2 hours should separate a dose of dexamethasone from a dose of BBI608.
BortezomibDrug
Also called Velcade
Bortezomib will be administered at 1.3 mg/m2/dose as a 3-5 second bolus intravenous (IV) injection or subcutaneous injection twice weekly for 2 weeks (Day 1, 4, 8, and 11) followed by a 10-day rest period (Day 12-21).
ImatinibDrug
Also called Gleevec
Imatinib will be taken orally once daily with a meal and a large glass of water. For patients having difficulty swallowing, imatinib can be dissolved in water or apple juice for intake. The dose of imatinib is 400 mg for CML patients in the chronic phase and 600 mg for CML patients in the accelerated phase or in blast crisis. A minimum of 2 hours should separate a dose of imatinib from a dose of BBI608.
IbrutinibDrug
Also called Imbruvica
Ibrutinib will be taken orally once daily with water. Do not open, break, or chew the capsules. The dose of ibrutinib is 420 mg for patients with normal liver function and is 140 mg for patients with mild liver impairment (Child-Pugh class A). A minimum of 2 hours should separate a dose of ibrutinib from a dose of BBI608.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients with multiple myeloma treated with BBI608 Receives: Drug: BBI608 |
| Arm 2 | Experimental | Patients with lymphoma treated with BBI608 Receives: Drug: BBI608 |
| Arm 3 | Experimental | Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608 Receives: Drug: BBI608 |
| Arm 4 | Experimental | Patients with chronic myeloid leukemia treated with BBI608 Receives: Drug: BBI608 |
| Arm 5 | Experimental | Patients with multiple myeloma treated with BBI608 and dexamethasone Receives: Drug: BBI608; Drug: Dexamethasone |
| Arm 6 | Experimental | Patients with multiple myeloma treated with BBI608 and bortezomib Receives: Drug: BBI608; Drug: Bortezomib |
| Arm 7 | Experimental | Patients with chronic myeloid leukemia treated with BBI608 and imatinib Receives: Drug: BBI608; Drug: Imatinib |
| Arm 8 | Experimental | Patients with chronic lymphocytic leukemia treated with BBI608 Receives: Drug: BBI608 |
| Arm 9 | Experimental | Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib Receives: Drug: BBI608; Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the safety and tolerability of BBI608 administered as monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib by assessing dose-limiting toxicities (DLTs)
Measured: 4 weeks
Secondary outcomes (3)
Pharmacokinetic profile of BBI608 when administered in monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib as assessed by maximum plasma concentration and area under the curve
Measured: -5min, 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, 11, 12 hours on day 1, cycles 1 and 2
Pharmacodynamic activity of BBI608 when administered in monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib as assessed by biomarker analysis
Histopathology and Cancer Stem Cell assays will be performed to provide information of the biomarkers on patient blood samples collected on-study, as well as on (if available) bone marrow, other biopsied patient tumor tissue, and archival samples.
Measured: 20 weeks
Assessment of the preliminary anti-tumor activity by performing tumor assessments
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startMay 2015
- Primary completion14 Dec 2018
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT02352558
- Sponsor's protocol ID
- BBI608-103HEME
- Other IDs
- BBI608-103HEM
- Status last verified
- Nov 2023
- First submitted
- 26 Jan 2015
- Last updated
- 14 Nov 2023
- Results posted
- 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 Ib Clinical Study of BBI608 for Adult Patients With Advanced, Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02352558
- Acronym / sponsor ID
- BBI608-103HEME
- Conditions
- Hematologic Malignancy
- Keywords
- Multiple Myeloma, Lymphoma, Acute Myeloid Leukemia, Myelo-Dysplastic Syndrome, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 2 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 a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BBI608Patients with multiple myeloma treated with BBI608 |
| Arm 2 | Experimental | Drug: BBI608Patients with lymphoma treated with BBI608 |
| Arm 3 | Experimental | Drug: BBI608Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608 |
| Arm 4 | Experimental | Drug: BBI608Patients with chronic myeloid leukemia treated with BBI608 |
| Arm 5 | Experimental | Drug: BBI608, Drug: DexamethasonePatients with multiple myeloma treated with BBI608 and dexamethasone |
| Arm 6 | Experimental | Drug: BBI608, Drug: BortezomibPatients with multiple myeloma treated with BBI608 and bortezomib |
| Arm 7 | Experimental | Drug: BBI608, Drug: ImatinibPatients with chronic myeloid leukemia treated with BBI608 and imatinib |
| Arm 8 | Experimental | Drug: BBI608Patients with chronic lymphocytic leukemia treated with BBI608 |
| Arm 9 | Experimental | Drug: BBI608, Drug: IbrutinibPatients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-608Patients will receive BBI608 orally twice daily, with doses separated by approximately 12 hours. The starting dose for all cohorts will be 240 mg twice daily. Subsequently, cohorts at alternate dose-levels (480 mg twice daily) may be enrolled as determined by the criteria for dose-escalation. | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8, Arm 9 |
| DexamethasoneDexamethasone will be taken orally at a dose level of 40 mg once weekly, on Days 1, 8, 15, and 22 of each Cycle. Patients over the age of 75 years are allowed to begin dexamethasone at a dose of 20 mg once weekly, on Days 1, 8, 15, and 22 of each Cycle. Dexamethasone should be taken with food or milk, and a minimum of 2 hours should separate a dose of dexamethasone from a dose of BBI608. | Drug | Arm 5 |
| BortezomibAlso: VelcadeBortezomib will be administered at 1.3 mg/m2/dose as a 3-5 second bolus intravenous (IV) injection or subcutaneous injection twice weekly for 2 weeks (Day 1, 4, 8, and 11) followed by a 10-day rest period (Day 12-21). | Drug | Arm 6 |
| ImatinibAlso: GleevecImatinib will be taken orally once daily with a meal and a large glass of water. For patients having difficulty swallowing, imatinib can be dissolved in water or apple juice for intake. The dose of imatinib is 400 mg for CML patients in the chronic phase and 600 mg for CML patients in the accelerated phase or in blast crisis. A minimum of 2 hours should separate a dose of imatinib from a dose of BBI608. | Drug | Arm 7 |
| IbrutinibAlso: ImbruvicaIbrutinib will be taken orally once daily with water. Do not open, break, or chew the capsules. The dose of ibrutinib is 420 mg for patients with normal liver function and is 140 mg for patients with mild liver impairment (Child-Pugh class A). A minimum of 2 hours should separate a dose of ibrutinib from a dose of BBI608. | Drug | Arm 9 |
Primary outcome
Determination of the safety and tolerability of BBI608 administered as monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib by assessing dose-limiting toxicities (DLTs)
Time frame: 4 weeks
3 secondary outcomes
Pharmacokinetic profile of BBI608 when administered in monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib as assessed by maximum plasma concentration and area under the curve
Time frame: -5min, 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, 11, 12 hours on day 1, cycles 1 and 2
Pharmacodynamic activity of BBI608 when administered in monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib as assessed by biomarker analysis
Time frame: 20 weeks
Assessment of the preliminary anti-tumor activity by performing tumor assessments
Time frame: 20 weeks
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.
8 sites 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, Dexamethasone and Bortezomib in people with Hematologic Malignancy, run by Sumitomo Pharma America, Inc. at 8 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?
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 8 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 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?
Determination of the safety and tolerability of BBI608 administered as monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib by assessing dose-limiting toxicities (DLTs) (time frame: 4 weeks). 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.