Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113724
Status:
COMPLETED
Last Update Posted:
2009-06-04
First Post:
2005-06-09
Brief Title:
Study of TPI 287 in Patients With Advanced Malignancies
Sponsor:
Cortice Biosciences Inc
Organization:
Cortice Biosciences Inc
Study Overview
Official Title:
A Phase I Open-Label Dose Escalation Multi-Center Study of TPI 287 in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tapestry Pharmaceuticals Inc has developed a novel taxane analog TPI 287 TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding This study will be a multi-center dose escalation sequential group phase I study evaluating the intravenous administration of TPI 287 a novel third generation taxane
Detailed Description:
The primary objective of this study is to determine the maximum tolerated dose of TPI 287 for phase II clinical trials
The secondary objectives of the study are
To determine the safety of TPI 287
To determine antitumor activity of TPI 287
To determine the pharmacokinetic profile of TPI 287
To determine the pharmacodynamic profile of TPI 287
The secondary objectives of the study are
To determine the safety of TPI 287
To determine antitumor activity of TPI 287
To determine the pharmacokinetic profile of TPI 287
To determine the pharmacodynamic profile of TPI 287
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