Phase Ib With Expansion of Patients at the MTD Study of Olaparib Plus Weekly (Metronomic) Carboplatin and Paclitaxel in Relapsed Ovarian Cancer Patients

Trial ID # NCT01650376
Phase 1b
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Carboplatin, Olaparib, Paclitaxel
Eligible Participant

Recurrent ovarian cancer

Patients Enrolled

Phase Ib: 14; Expansion: 40; median 3 prior therapies

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, PFS, OS, RP2D, evaluated per RECIST

Efficacy

RP2D: 150 mg olaparib (tablet) BID, metronomic carboPt AUC2 and paclitaxel 60 mg/m2

ORR: 54% (13CR, 16PR, n=54)

Exploratory analysis, BRCA status:
BRCA MUT (n=23) vs BRCA WT (n=24):
PFS: 12.1 vs 4.8 months (p=0.0001)
OS: 24.1 vs 10.4 months (p=0.02)

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: 78%

Conclusion

Olaparib can be safely administered with metronomic carboplatin and paclitaxel in recurrent ovarian cancer, but BRCA MUT patients experience most benefit

Reference

Rivkin SE et al., Phase Ib with expansion study of olaparib plus weekly (Metronomic) carboplatin and paclitaxel in relapsed ovarian cancer patients. Int J of Gynecol Cancer (2019) 29(2): 325-333
https://www.ncbi.nlm.nih.gov/pubmed/30700568

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