Trial ID # | NCT01078662; Study 42 |
Phase | II |
Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
Drug Name | Olaparib |
Alternate Drug Names | AZD2281, Lynparza |
Drugs in Trial | Olaparib |
Eligible Participant | Advanced gBRCA-mutated cancer with ≥ 3 prior therapies |
Patients Enrolled | 299; median 5 prior therapies (1-14) |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, DoR, PFS, evaluated per RECIST |
Biomarkers | gBRCA1/2 MUT |
Efficacy | ORR: 34% (2CR, 44PR, n=137) Exploratory analysis Pt status: |
Clinically Significant Adverse Events | Serious AE: none |
Conclusion | Promising responses in heavily pretreated gBRCA MUT patients |
Reference | Domchek et al. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol (2016) 140: 199-203 |