Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients
To determine the maximum tolerated dose (MTD) of CRA-024781 IV given by 2-hour intravenous infusions in patients with refractory solid or hematologic malignancies. To evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and to evaluate bioavailability of CRA-024781 IV when administered in a single oral dose.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Two Phase, Open-Label, Sequential, Ascending Dose Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients|
|Study Start Date:||August 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Patients will receive a single oral dose of CRA-024781 one week before beginning intravenous dosing. Blood samples for pharmacokinetic and pharmacodynamic analysis will be collected on several occasions prior to the start of the intravenous treatment.
The intravenous treatment will consist of 3 consecutive days of CRA-024781 IV administered as a 2-hour IV infusion every 3 weeks in a 4 weeks cycle.
Assessment of the extent of disease will be performed every 8 weeks.