Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 8:51 AM
Study NCT ID:
NCT00741403
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2008-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Open Label Phase I/II Clinical Trial to Evaluate CPI-613 in Patients With Advanced Malignancies
Sponsor:
Cornerstone Pharmaceuticals
Organization:
Study Overview
Official Title:
An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2016-12
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:
An open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose (MTD), efficacy, and pharmacokinetics (PKs) of CPI-613 given twice weekly for three consecutive weeks in cancer patients
The objectives of this study are:
* To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
* To determine pharmacokinetics of CPI-613 following intravenous (IV) administration.
* To observe the anti-tumor effects of CPI-613, if any occur.
The objectives of this study are:
* To determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.
* To determine pharmacokinetics of CPI-613 following intravenous (IV) administration.
* To observe the anti-tumor effects of CPI-613, if any occur.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: