Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100347
Status:
TERMINATED
Last Update Posted:
2007-07-25
First Post:
2004-12-29
Brief Title:
SafetyTolerance Study of PPI-2458 in Subjects With Non-Hodgkins Lymphoma and Solid Tumors
Sponsor:
PRAECIS Pharmaceuticals Inc
Organization:
PRAECIS Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Dose Escalation SafetyTolerance Study of PPI-2458 in Subjects With Non-Hodgkins Lymphoma and Solid Tumors
Status:
TERMINATED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated due to corporate transaction
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 multi-center open-label escalating dose study is to assess the safety and tolerability of PPI-2458 in subjects with Non-Hodgkins Lymphoma NHLand solid tumors Subjects will be treated every other day QOD with PPI-2458 while being monitored closely for adverse events
Detailed Description:
The study will first determine the dose level that maximally inhibits MetAP2 in white blood cells WBC Once this dose level is reached the study will proceed into the next cohort dose level to investigate the dose level that maximally inhibits MetAP2 in tumor tissue biopsies Free MetAP2 levels WBC andor tumor tissue will be analyzed during the first cycle 28 days of treatment Cohorts are expected to enroll every two cycles until the maximum tolerated dose MTDis determined
After the Initial Treatment Phase of two treatment cycles of PPI-2458 subjects may continue into a Continuous Treatment Phase at the discretion of the Investigator In order to be eligible for the Continuous Treatment Phase of the protocol subjects must have received some benefit eg stable disease as assessed by the Investigator within the Initial Treatment Phase and must continue to meet inclusion and exclusion criteria
After the Initial Treatment Phase of two treatment cycles of PPI-2458 subjects may continue into a Continuous Treatment Phase at the discretion of the Investigator In order to be eligible for the Continuous Treatment Phase of the protocol subjects must have received some benefit eg stable disease as assessed by the Investigator within the Initial Treatment Phase and must continue to meet inclusion and exclusion criteria
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