This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
intravenous infusion administered twice a week for 2 weeks
Research Site
New York, New York, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities
Time frame: on a twice a week schedule for two weeks out of every three weeks
To evaluate the safety and tolerability of AZD4877 by assessment of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade and type of AE, changes in laboratory values, vital signs, and incidence of protocol defined dose modification
Time frame: assessed after each course of treatment
Dose Expansion (Part B):Estimate efficacy of AZD4877 through evaluation of objective response rate, progression-free survival and disease control rate in patients with B-cell non-Hodgkin lymphoma using the revised response criteria for malignant lymphoma
Time frame: Assessed during treatment and post treatment
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