Trials / Completed
CompletedNCT00628251
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- Female
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD2281 | 400mg Oral twice daily |
| DRUG | Liposomal Doxorubicin | 50mg/m2 Monthly Intravenous |
| DRUG | AZD2281 | 200mg oral twice daily |
Timeline
- Start date
- 2008-07-30
- Primary completion
- 2009-09-15
- Completion
- 2018-09-19
- First posted
- 2008-03-05
- Last updated
- 2019-12-05
- Results posted
- 2016-06-03
Locations
24 sites across 9 countries: United States, Australia, Belgium, Germany, Israel, Poland, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00628251. Inclusion in this directory is not an endorsement.