Trials / Completed
CompletedNCT00516373
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 98 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KU-0059436 (AZD2281)(PARP inhibitor) | oral |
Timeline
- Start date
- 2005-07-11
- Primary completion
- 2008-12-17
- Completion
- 2023-04-26
- First posted
- 2007-08-15
- Last updated
- 2024-02-22
Locations
5 sites across 4 countries: Belgium, Netherlands, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT00516373. Inclusion in this directory is not an endorsement.