Phase 2
N=57
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
Ovarian Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT00494442 ↗Enrolled (actual)
57
Serious AEs
33.3%
Results posted
Jan 2015
Primary outcome: Primary: Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) — 3; 11; 3; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KU-0059436 (AZD2281)(PARP inhibitor) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) |
3; 11; 3; 11 | — |
| SECONDARY Clinical Benefit (CB) |
45.5; 71.0 | — |
| SECONDARY Duration of Response |
242; 301 | — |
| SECONDARY Best Percentage Change in Tumour Size |
-5.1; -25.8 | — |
| SECONDARY Progression-Free Survival (PFS) |
62.5; 226 | — |
Summary
The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.
Eligibility Criteria
Inclusion Criteria
- Advanced ovarian cancer with positive BRCA1 or BRCA2 status
- Failed at least one prior chemotherapy
- In investigators opinion, no curative standard therapy exists
- Measurable disease
Exclusion Criteria
- 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 (NCT00494442). 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.