Phase 1 Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy
This is an open-label, single arm study. Approximately 4-48 patients will be enrolled.
Patients will receive 800mg/day of Clioquinol at the start of the trial and the dose will be
increased by 800mg with each subsequent level until the MTD is determined. Patients will
then increase their frequency of the drug. Response to Clioquinol will be determined on day
21 for the 8 and 15 day dosing schedule and on day 28 for the 22 day dosing schedule ( 1
cycle). Patients who have demonstrated a response to the drug will be eligible to receive
up to 5 additional cycles at the same dose and frequency every 21 days.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the dose-limiting toxicity (DLT), maximum tolerated dose, and recommended phase II dose. To partially characterize the pharmacokinetics of Clioquinol in plasma following single and multiple oral dosing.
Mark Minden, MD
Princess Margaret Hospital, Canada
Canada: Health Canada