Trial ID # | Rucaparib FDA Approval Data |
Phase | II |
Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
Drug Name | Rucaparib |
Alternate Drug Names | AG-014699, PF 01367338, CO-338, Rubraca |
Drugs in Trial | Rucaparib |
Eligible Participant | BRCA-mutated cancer with ≥ 2 prior therapies |
Patients Enrolled | 106; median 2 prior therapies |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, DoR, evaluated per RECIST |
Biomarkers | BRCA1/2 MUT |
Efficacy | ORR: 54% (9CR, 48PR, n=106) Exploratory analysis Pt status: |
Clinically Significant Adverse Events | Serious AE: none |
Conclusion | Promising responses in BRCA MUT patients |
Reference | Rubraca Prescribing Info, Version 04/2018 |