Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001302
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833
Status:
COMPLETED
Status Verified Date:
2002-06
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 clinical study entitled A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833 seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist PSC 833 PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable The purpose of this study is to define the maximum tolerated dose in combination with vinblastine and to determine how the drug affects the pharmacokinetics of vinblastine PSC 833 will most likely reduce the clearance of vinblastine as reported for the parent compound cyclosporine This effect will increase the area under the curve AUC of vinblastine may increase toxicity and requires that the escalation scheme for PSC 833 be a conservative one Initially a 120 hour infusion of vinblastine will be given alone Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone This first cycle of vinblastine will be given in the absence of PSC 833 in second and subsequent cycles both agents will be combined Escalation of the PSC 833 will continue until a target concentration is reached or until the maximum tolerated dose is reached Clinical responses will be monitored in order to provide the best possible medical care to our patients
Detailed Description:
The clinical study entitled A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833 seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist PSC 833 PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive It has been shown in in vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable The purpose of this study is to define the maximum tolerated dose in combination with vinblastine and to determine how the drug affects the pharmacokinetics of vinblastine PSC 833 will most likely reduce the clearance of vinblastine as reported for the parent compound cyclosporine This effect will increase the area under the curve AUC of vinblastine may increase toxicity and requires that the escalation scheme for PSC 833 be a conservative one Initially a 120 hour infusion of vinblastine will be given alone Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone This first cycle of vinblastine will be given in the absence of PSC 833 in second and subsequent cycles both agents will be combined Escalation of the PSC 833 will continue until a target concentration is reached or until the maximum tolerated dose is reached Clinical responses will be monitored in order to provide the best possible medical care to our patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-C-0268 | None | None | None |