The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.
This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose (MTD) of belinostat when administered in combination with CHOP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Belinostat will be administered by intravenous infusion once daily for up to 5 days depending on the dose cohort as follows: * Cohort 1: belinostat 1000 mg/m2 IV on Day 1 * Cohort 2: belinostat 1000 mg/m2 IV on Day 1-2 * Cohort 3: belinostat 1000 mg/m2 IV on Day 1-3 * Cohort 4: belinostat 1000 mg/m2 IV on Day 1-4 * Cohort 5: belinostat 1000 mg/m2 IV on Day 1-5
Cyclophosphamide - 750 mg/m2 - IV - Day 1 Vincristine - 1.4 mg/m2 - IV - Day 1 Doxorubicin - 50mg/m2 - IV - Day 1 Prednisone 100mg PO - On Day 1 Prednisone will be administered after chemotherapy part of CHOP, and on Day 2-5 after belinostat.
Yale University
New Haven, Connecticut, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
Maximum Tolerated Dose (MTD)
To determine the MTD for belinostat when combined with CHOP regimen and establish the Phase 3 recommended belinostat dose.
Time frame: up to 5 days
Safety and tolerance
To assess safety and tolerance of belinostat when given in combination with CHOP regimen. Safety and tolerance will be mainly characterized by the number and severity of treatment emergent adverse events, and treatment related AEs that occur or worsen after the first dose of study treatment.
Time frame: up to 5 days
Overall Response Rate
Overall response rate (ORR) after 6 cycles of BelCHOP regimen
Time frame: 126 days
Effectiveness of study drug
Pharmacokinetics of belinostat when co-administered with CHOP regimen. The concentration of Belinostat to assess the effectiveness.
Time frame: 126 days
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St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Hematology - Oncology Associates of Northern NJ P.A
Morristown, New Jersey, United States
Columbia University Medical Center/Center for Lymphiod Malignancies
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States