Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Boehringer Ingelheim
OBJECTIVES: Primary * 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. Secondary * 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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
