| Trial ID # | NCT01623349 |
| Phase | I |
| Drug Class | DNA Damage Repair Pathway Inhibitors: PARP |
| Drug Name | Olaparib |
| Alternate Drug Names | AZD2281, Lynparza |
| Drugs in Trial | Alpelisib, Olaparib |
| Eligible Participant | Advanced solid tumors (OvCa: HGS or gBRCA MUT of any histology) |
| Patients Enrolled | 118 [28 ovarian; 21 HGS, 5 poorly differentiated adenocarcinoma NOS, 1 carcinosarcoma, 1 mixed HGS and transitional cell carcinoma; median 3 prior therapies (2-5)] |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, DoR, PFS, OS, RP2D, evaluated per RECIST |
| Biomarkers | Exploratory: gBRCA1/2 |
| Efficacy | RP2D: Alp 200 mg qd and Ola 200 mg bid Exploratory analysis BRCA status in Pt-R/Pt-Rf patients: |
| Clinically Significant Adverse Events | Dose Limiting Toxicities: hyperglycemia (n=2), rash (n=1), neutropenia and fever (n=1) |
| Conclusion | Encouraging activity of alpelisib+olaparib combination in gBRCA WT patients |
| Reference | Konstantinopoulos PA et al. Olaparib and alpha-specific PI3K inhibitor alpelisib for patients with epithelial ovarian cancer: a dose-escalation and dose-expansion phase 1b trial. Lancet (2019) 20(4):570-580 |