Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473577
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2007-05-11
Brief Title:
Study of the Tolerability Safety and Pharmacokinetics of CRA-024781 in Cancer Patients
Sponsor:
Pharmacyclics LLC
Organization:
Pharmacyclics LLC
Study Overview
Official Title:
Two Phase Open-Label Sequential Ascending Dose Study of the Tolerability Safety and Pharmacokinetics of CRA-024781 in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None