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A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies

Primary Purpose

Hematologic Malignancy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BBI608
Dexamethasone
Bortezomib
Imatinib
Ibrutinib
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancy focused on measuring Multiple Myeloma, Lymphoma, Acute Myeloid Leukemia, Myelo-Dysplastic Syndrome, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major Inclusion Criteria:

  1. 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
  2. A histologically confirmed hematologic malignancy that is advanced, relapsed, or refractory to standard, currently available anti-cancer treatment options
  3. ≥ 18 years of age
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at dose escalation phase and of ≤ 2 at dose expansion phase
  5. 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
  6. Females of childbearing potential must have a negative serum pregnancy test
  7. 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
  8. 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
  9. Life expectancy ≥ 3 months

Sites / Locations

  • Rocky Mountain Cancer Centers
  • Indiana University
  • West Clinic
  • Cancer Care Centers of South Texas
  • Cancer Care Centers of South Texas - HOAST
  • Virginia Cancer Specialists, P.C.
  • Virginia Oncology Associates
  • Northwest Cancer Specialists, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Description

Patients with multiple myeloma treated with BBI608

Patients with lymphoma treated with BBI608

Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608

Patients with chronic myeloid leukemia treated with BBI608

Patients with multiple myeloma treated with BBI608 and dexamethasone

Patients with multiple myeloma treated with BBI608 and bortezomib

Patients with chronic myeloid leukemia treated with BBI608 and imatinib

Patients with chronic lymphocytic leukemia treated with BBI608

Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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.
Assessment of the preliminary anti-tumor activity by performing tumor assessments

Full Information

First Posted
January 26, 2015
Last Updated
April 4, 2022
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02352558
Brief Title
A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies
Official Title
A Phase Ib Clinical Study of BBI608 for Adult Patients With Advanced, Refractory Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
May 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy
Keywords
Multiple Myeloma, Lymphoma, Acute Myeloid Leukemia, Myelo-Dysplastic Syndrome, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients with multiple myeloma treated with BBI608
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Patients with lymphoma treated with BBI608
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
Patients with chronic myeloid leukemia treated with BBI608
Arm Title
Arm 5
Arm Type
Experimental
Arm Description
Patients with multiple myeloma treated with BBI608 and dexamethasone
Arm Title
Arm 6
Arm Type
Experimental
Arm Description
Patients with multiple myeloma treated with BBI608 and bortezomib
Arm Title
Arm 7
Arm Type
Experimental
Arm Description
Patients with chronic myeloid leukemia treated with BBI608 and imatinib
Arm Title
Arm 8
Arm Type
Experimental
Arm Description
Patients with chronic lymphocytic leukemia treated with BBI608
Arm Title
Arm 9
Arm Type
Experimental
Arm Description
Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib
Intervention Type
Drug
Intervention Name(s)
BBI608
Other Intervention Name(s)
Napabucasin, BB608, BBI-608
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
Imbruvica
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Pharmacodynamic activity of BBI608 when administered in monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib as assessed by biomarker analysis
Description
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.
Time Frame
20 weeks
Title
Assessment of the preliminary anti-tumor activity by performing tumor assessments
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
West Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Cancer Care Centers of South Texas - HOAST
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Cancer Specialists, P.C.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies

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