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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT02352558
Phase
PHASE1
Status
Completed

Conditions

  • Hematologic Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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).
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Nov 2023
Primary completion
Dec 14, 2018
Completion
May 16, 2019

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Patients with multiple myeloma treated with BBI608
  • Experimental: Arm 2
    Patients with lymphoma treated with BBI608
  • Experimental: Arm 3
    Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608
  • Experimental: Arm 4
    Patients with chronic myeloid leukemia treated with BBI608
  • Experimental: Arm 5
    Patients with multiple myeloma treated with BBI608 and dexamethasone
  • Experimental: Arm 6
    Patients with multiple myeloma treated with BBI608 and bortezomib
  • Experimental: Arm 7
    Patients with chronic myeloid leukemia treated with BBI608 and imatinib
  • Experimental: Arm 8
    Patients with chronic lymphocytic leukemia treated with BBI608
  • Experimental: Arm 9
    Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib

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 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer CentersDenverColorado80218-
Indiana UniversityIndianapolisIndiana46202-
West ClinicGermantownTennessee38138-
Cancer Care Centers of South TexasSan AntonioTexas78217-
Cancer Care Centers of South Texas - HOASTSan AntonioTexas78229-
Virginia Cancer Specialists, P.C.FairfaxVirginia22031-
Virginia Oncology AssociatesNorfolkVirginia23502-
Northwest Cancer Specialists, PCVancouverWashington98684-

Find similar trials in Denver, CO

By research site
Rocky Mountain Cancer Centers· Denver, COIndiana University· Indianapolis, INWest Clinic· Germantown, TNCancer Care Centers of South Texas· San Antonio, TXCancer Care Centers of South Texas - HOAST· San Antonio, TXVirginia Cancer Specialists, P.C.· Fairfax, VA

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