At a glance
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A Phase I/II Study of Dasatinib in Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) (BMS Protocol 180129)
In Brief
A Phase 2 clinical trial evaluating Dasatinib and Dasatinib Maximum Tolerated Dose for Non-Hodgkin's Lymphoma. Completed, enrolled 38 participants across 1 site.
Detailed Summary
Primary Objective: * To determine the maximum tolerated dose (MTD) of Dasatinib in relapsed or refractory non-hodgkin's lymphoma (NHL) patients and to determine the safety of Dasatinib in NHL. Secondary Objectives: * To assess the complete and overall response rates for all Phase I and Phase II patients and to determine overall survival and event free survival for all Phase I and Phase II patients. * To assay the levels of kinase activity in NHL specimens and correlate this activity to patient outcomes.
Study Details
Timeline
Interventions
Dasatinib will be orally administered once daily for 28 day cycles. There will be three dose cohorts for the Dasatinib in the Phase I portion of this trial. A minimum of three patients will be enrolled into each of the following dose cohorts: Dose cohort # 1 will be 100 mg per day Dose cohort # 2 will be 150 mg per day Dose cohort # 3 will be 200 mg per day The MTD will be determined in the Phase I portion of this trial.
An additional 29 patients using the Two-Stage Simon design will be enrolled into Phase II using the MTD determined in Phase I.