Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422786
Status:
COMPLETED
Last Update Posted:
2008-07-15
First Post:
2007-01-12
Brief Title:
Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
Sponsor:
Thallion Pharmaceuticals
Organization:
Thallion Pharmaceuticals
Study Overview
Official Title:
A Multi-Centre Open Label Phase II Study of the Safety Efficacy and Pharmacokinetic PK Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer
Status:
COMPLETED
Status Verified Date:
2008-07
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:
The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated refractory renal cell carcinoma
Detailed Description:
This was a multi-center open label single arm study Approximately 40 patients were initially planned to be recruited
Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 048 mgkgday followed by a 7-day rest period Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity
Quality of Life questionnaires were to be administered at baseline after each visit and at the end of the study
Signs and symptoms of adverse events were closely monitored during treatment cycles Safety laboratory measures were done at Screening during the 72hr hospitalization first cycle at every interim visit and at the end of the study A follow-up safety visit was to be scheduled at least 30 days after the end of treatment
CAP-232 plasma levels were also determined
Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 048 mgkgday followed by a 7-day rest period Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity
Quality of Life questionnaires were to be administered at baseline after each visit and at the end of the study
Signs and symptoms of adverse events were closely monitored during treatment cycles Safety laboratory measures were done at Screening during the 72hr hospitalization first cycle at every interim visit and at the end of the study A follow-up safety visit was to be scheduled at least 30 days after the end of treatment
CAP-232 plasma levels were also determined
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