Phase 2
Completed N=57
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
Source: ClinicalTrials.gov NCT00494442 ↗Enrolled (actual)
57
Serious AEs
33.3%
Results posted
Jan 2015
Primary outcomePrimary: Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) — 3; 11; 3; 11 Participants
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.
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 | — |
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. Informational only — not medical advice.