Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-31 @ 11:04 PM
Study NCT ID:
NCT00997360
Status:
WITHDRAWN
Last Update Posted:
2018-09-27
First Post:
2009-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PKI-179 Administered Orally to Subjects With Solid Tumors
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Study Overview
Official Title:
A Phase 1 Study of PKI-179 Administered Orally to Subjects With Solid Tumors
Status:
WITHDRAWN
Status Verified Date:
2018-09
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:
This is an open label dose escalation study to find the maximum tolerated dose (MTD) of PKI-179 in subjects with solid tumors. Part 1 of the study will be the dose estimation phase and will be open to subjects with all solid tumors. Part 2 will be the dose confirmation phase and will be open to subjects with breast, non small cell lung, ovarian, endometrial, or colorectal cancer or glioblastoma. All subjects will receive daily oral dosing of PKI-179. A continuous reassessment method (CRM) design will be used, which will take into account dose limiting toxicity (DLT) information from each dose level explored in order to determine the next dose level.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: