Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465725
Status:
COMPLETED
Last Update Posted:
2009-09-24
First Post:
2007-04-23
Brief Title:
A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
Sponsor:
Poniard Pharmaceuticals
Organization:
Poniard Pharmaceuticals
Study Overview
Official Title:
A Randomized Crossover Oral Bioavailability Study Comparing the Pharmacokinetics and Pharmacodynamics of Picoplatin Administered Orally With Picoplatin Administered Intravenously in Subjects With Advanced Non-Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
2009-09
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:
Picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of cancers Phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients whose cancer returns or does not improve after treatment with chemotherapy In these studies picoplatin was administered intravenously A capsule containing picoplatin has been formulated This study will investigate the activity of the oral capsule in humans Participants with advanced solid tumors will be enrolled
Detailed Description:
The primary study design is a randomized two-period crossover open label study in which a single dose Cycle 1 of picoplatin will be given either IV or by oral capsule followed 4 weeks later by a single dose Cycle 2 of picoplatin given either IV or by oral capsule whichever route was not used in Cycle 1 Participants may continue to receive cycles of IV picoplatin every 3 weeks beginning with Cycle 3 as part of a Continuation Study
This study will determine the relative safety bioavailability pharmacokinetics pharmacodynamics and urinary excretion of picoplatin administered orally with reference to picoplatin administered intravenously
This study will determine the relative safety bioavailability pharmacokinetics pharmacodynamics and urinary excretion of picoplatin administered orally with reference to picoplatin administered intravenously
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