Phase 2
N=97
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
Ovarian Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00628251 ↗Enrolled (actual)
97
Serious AEs
16.7%
Results posted
Jun 2016
Primary outcome: Primary: Progression Free Survival (PFS) — 19; 20; 20 Participants — p=0.6604
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD2281 (Drug); Liposomal Doxorubicin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
6.5; 8.8; 7.1 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 0; 0; 8; 10; 6 | 0.1291 |
| SECONDARY Disease Control Rate |
21; 21; 19 | — |
| SECONDARY Overall Duration of Response |
5.95; 6.80; 6.24; 5.49 | — |
| SECONDARY Best Percentage Change in Tumour Size |
-15.90; -24.60; -14.3 | — |
| SECONDARY Best Percentage Change From Baseline in CA-125 Levels |
-37.42; -71.19; -55.8 | — |
| SECONDARY Confirmed RECIST Response and/or CA-125 Response |
37.5; 59.4; 39.4 | — |
| SECONDARY Overall Survival (OS) |
9; 11; 13 | 0.5781 |
| SECONDARY Best Quality of Life (QoL) Response for Trial Outcome Index (TOI) |
7; 5; 3; 10; 10; 11 | — |
| SECONDARY Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) |
3; 6; 1; 14; 11; 11 | — |
| SECONDARY Best QoL Response for FACT-O Symptom Index (FOSI) |
5; 4; 3; 14; 9; 10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Advanced ovarian cancer with positive BRCA1 or BRCA2 status
- Progressive or recurrent disease after platinum-based chemotherapy
- Measurable disease by RECIST
Exclusion Criteria
- Previous anthracycline treatment
- Brain metastases
- Less than 28 days since last treatment used to treat the disease
- Considered a poor medical risk due to a serious uncontrolled disorder
Data sourced from ClinicalTrials.gov (NCT00628251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.