NCT00473577

Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients

Two Phase, Open-Label, Sequential, Ascending Dose Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Hematologic Neoplasms
• Neoplasms

Interventions

Type	Name	Description
DRUG	CRA-24781

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2007-05-15
• Last updated: 2010-08-25

Locations

1 site across 1 country: United States