An Open Phase I Single Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
- Determine the maximum tolerated dose of BI 2536 in patients with refractory or relapsed
advanced aggressive non-Hodgkin's lymphoma.
- Determine the safety and tolerability of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, open-label, uncontrolled, multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BI 2536 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity during the first treatment course. Up to 24 patients are
treated at the MTD.
After completion of study treatment, patients are followed periodically until disease
progression or initiation of another cancer treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course
Julie M. Vose, MD
University of Nebraska
United States: Food and Drug Administration
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|