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| ID | Type | Description | Link |
|---|---|---|---|
| BBI608-103HEM | Other Identifier | Sumitomo Dainippon Pharma Oncology, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients with multiple myeloma treated with BBI608 |
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| Arm 2 | Experimental | Patients with lymphoma treated with BBI608 |
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| Arm 3 | Experimental | Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608 |
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| Arm 4 | Experimental | Patients with chronic myeloid leukemia treated with BBI608 |
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| Arm 5 | Experimental | Patients with multiple myeloma treated with BBI608 and dexamethasone |
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| Arm 6 | Experimental | Patients with multiple myeloma treated with BBI608 and bortezomib |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBI608 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Major Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States | ||
| Indiana University |
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| Arm 7 | Experimental | Patients with chronic myeloid leukemia treated with BBI608 and imatinib |
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| Arm 8 | Experimental | Patients with chronic lymphocytic leukemia treated with BBI608 |
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| Arm 9 | Experimental | Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib |
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| Dexamethasone | Drug | 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. |
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| Bortezomib | Drug | 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). |
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| Imatinib | Drug | 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. |
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| Ibrutinib | Drug | 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. |
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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. |
| 20 weeks |
| Assessment of the preliminary anti-tumor activity by performing tumor assessments | 20 weeks |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| West Clinic | Germantown | Tennessee | 38138 | United States |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | United States |
| Cancer Care Centers of South Texas - HOAST | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists, P.C. | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Northwest Cancer Specialists, PC | Vancouver | Washington | 98684 | United States |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
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| ID | Term |
|---|---|
| C000621033 | napabucasin |
| D003907 | Dexamethasone |
| D000069286 | Bortezomib |
| D000068877 | Imatinib Mesylate |
| C551803 | ibrutinib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D011743 | Pyrimidines |
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