Neoplasms Clinical Trial
Official title:
Two Phase, Open-Label, Sequential, Ascending Dose 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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