Study of the Tolerability, Safety, and Pharmacokinetics of CRA-024781 in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00473577|
Recruitment Status : Completed
First Posted : May 15, 2007
Last Update Posted : August 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Neoplasms Neoplasms||Drug: CRA-24781||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||December 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473577
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60643|
|Principal Investigator:||Samir Undevia, MD||University of Chicago|