Phase II, Open-Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of Olaparib, a Poly (ADP-Ribose) Polymerase Inhibitor, and Pegylated Liposomal Doxorubicin in Patients With BRCA1 or BRCA2 Mutations and Recurrent Ovarian Cancer

2012 ◽  
Vol 2012 ◽  
pp. 116-117 ◽  
Author(s):  
J.T. Thigpen
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Multicenter Study ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Recurrent Ovarian Cancer ◽  
Efficacy And Safety ◽  
Open Label ◽  
Polymerase Inhibitor ◽  
Brca2 Mutations

Phase II, Open-Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of Olaparib, a Poly (ADP-Ribose) Polymerase Inhibitor, and Pegylated Liposomal Doxorubicin in Patients With BRCA1 or BRCA2 Mutations and Recurrent Ovarian Cancer

2012 ◽  
Vol 30 (4) ◽  
pp. 372-379 ◽  
Author(s):  
Stan B. Kaye ◽  
Jan Lubinski ◽  
Ursula Matulonis ◽  
Joo Ern Ang ◽  
Charlie Gourley ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Patient Population ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Efficacy And Safety ◽  
Open Label ◽  
Significant Difference ◽  
Polymerase Inhibitor ◽  
Brca2 Mutations

Purpose Olaparib (AZD2281), an orally active poly (ADP-ribose) polymerase inhibitor that induces synthetic lethality in BRCA1- or BRCA2-deficient cells, has shown promising clinical efficacy in nonrandomized phase II trials in patients with ovarian cancer with BRCA1 or BRCA2 deficiency. We assessed the comparative efficacy and safety of olaparib and pegylated liposomal doxorubicin (PLD) in this patient population. Patients and Methods In this multicenter, open-label, randomized, phase II study, patients with ovarian cancer that recurred within 12 months of prior platinum therapy and with confirmed germline BRCA1 or BRCA2 mutations were enrolled. Patients were assigned in a 1:1:1 ratio to olaparib 200 mg twice per day or 400 mg twice per day continuously or PLD 50 mg/m2 intravenously every 28 days. The primary efficacy end point was Response Evaluation Criteria in Solid Tumors (RECIST) –assessed progression-free survival (PFS). Secondary end points included objective response rate (ORR) and safety. Results Ninety-seven patients were randomly assigned. Median PFS was 6.5 months (95% CI, 5.5 to 10.1 months), 8.8 months (95% CI, 5.4 to 9.2 months), and 7.1 months (95% CI, 3.7 to 10.7 months) for the olaparib 200 mg, olaparib 400 mg, and PLD groups, respectively. There was no statistically significant difference in PFS (hazard ratio, 0.88; 95% CI, 0.51 to 1.56; P = .66) for combined olaparib doses versus PLD. RECIST-assessed ORRs were 25%, 31%, and 18% for olaparib 200 mg, olaparib 400 mg, and PLD, respectively; differences were not statistically significant. Tolerability of both treatments was as expected based on previous trials. Conclusion The efficacy of olaparib was consistent with previous studies. However, the efficacy of PLD was greater than expected. Olaparib 400 mg twice per day is a suitable dose to explore in further studies in this patient population.

A multicenter open-label phase II study of the efficacy and safety of palbociclib a cyclin-dependent kinases 4 and 6 inhibitor in patients with recurrent ovarian cancer.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 5557-5557 ◽  
Author(s):  
Gottfried E. Konecny ◽  
Andrea Elisabeth Wahner Hendrickson ◽  
Aminah Jatoi ◽  
Jill K. Burton ◽  
Jill Paroly ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Recurrent Ovarian Cancer ◽  
Efficacy And Safety ◽  
Open Label ◽  
Cyclin Dependent Kinases ◽  
Open Label Phase

A multicenter phase II study of pegylated liposomal doxorubicin and oxaliplatin in recurrent ovarian cancer

2007 ◽  
Vol 106 (1) ◽  
pp. 164-169 ◽  
Author(s):  
Francesco Recchia ◽  
Gaetano Saggio ◽  
Giovanna Amiconi ◽  
Anna Di Blasio ◽  
Alisia Cesta ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase Ii ◽  
Liposomal Doxorubicin ◽  
Phase Ii Study ◽  
Pegylated Liposomal Doxorubicin ◽  
Recurrent Ovarian Cancer ◽  
Multicenter Phase
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