A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies
- Conditions
- Hematologic Malignancy
- Interventions
- Registration Number
- NCT02352558
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 BBI608 Patients with multiple myeloma treated with BBI608 Arm 5 BBI608 Patients with multiple myeloma treated with BBI608 and dexamethasone Arm 9 BBI608 Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib Arm 2 BBI608 Patients with lymphoma treated with BBI608 Arm 3 BBI608 Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608 Arm 4 BBI608 Patients with chronic myeloid leukemia treated with BBI608 Arm 6 BBI608 Patients with multiple myeloma treated with BBI608 and bortezomib Arm 7 BBI608 Patients with chronic myeloid leukemia treated with BBI608 and imatinib Arm 8 BBI608 Patients with chronic lymphocytic leukemia treated with BBI608 Arm 5 Dexamethasone Patients with multiple myeloma treated with BBI608 and dexamethasone Arm 6 Bortezomib Patients with multiple myeloma treated with BBI608 and bortezomib Arm 7 Imatinib Patients with chronic myeloid leukemia treated with BBI608 and imatinib Arm 9 Ibrutinib Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib
- Primary Outcome Measures
Name Time Method 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) 4 weeks
- Secondary Outcome Measures
Name Time Method 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 -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 20 weeks 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 20 weeks
Trial Locations
- Locations (8)
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
West Clinic
🇺🇸Germantown, Tennessee, United States
Northwest Cancer Specialists, PC
🇺🇸Vancouver, Washington, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Cancer Care Centers of South Texas - HOAST
🇺🇸San Antonio, Texas, United States
Virginia Cancer Specialists, P.C.
🇺🇸Fairfax, Virginia, United States