Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516373
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2007-08-13
Brief Title:
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 PARP
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 PARP-1 KU-0059436 in Patients With Advanced Tumours
Status:
COMPLETED
Status Verified Date:
2024-02
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:
To determine the safety tolerability dose-limiting toxicity DLT pharmacokinetic-pharmacodynamic profile and maximum tolerated dose MTD of KU-0059436 when administered orally to patients with advanced solid tumours To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population primarily ovarian cancer patients
Detailed Description:
None
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 |
|---|---|---|---|
| 2005-001435-29 | EUDRACT_NUMBER | None | None |
| D0810C00002 | None | None | None |