Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088023
Status:
TERMINATED
Last Update Posted:
2014-03-31
First Post:
2004-07-19
Brief Title:
Safety Study of PT-523 in Cancer Patients to Treat Solid Tumors Including a Preliminary Assessment of Effectiveness
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
A Phase I Study of PT-523 in Patients With Solid Tumors
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety of a short intravenous infusion of PT-523 to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist
Detailed Description:
The primary objectives of this study are 1 to evaluate the safety of a short intravenous infusion of PT-523 when administered on days 1 8 and 15 of a 28-day cycle to patients with solid tumors who have failed curative or survival prolonging therapy or for whom no such therapies exist and 2 to establish the maximum tolerated dose MTD and identify the dose limiting toxicities DLT of PT-523
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523
The secondary objectives of this study are to determine the pharmacokinetics and to evaluate preliminary efficacy of PT-523
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 |
|---|---|---|---|
| NSC No- 712783 | None | None | None |
| DFCI Legacy- 03-183 | None | None | None |
| CTEP Grant No- UO1-CA62490-09 | None | None | None |