A Open Label Phase II Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression

Trial ID #	NCT01536743
Phase	II
Drug Class	Cell Cycle Inhibitors: CDK4/6
Drug Name	Palbociclib
Alternate Drug Names	PD-0332991, PD0332991, Ibrance
Drugs in Trial	Palbociclib
Eligible Participant	Recurrent ovarian cancer
Patients Enrolled	40; median 3 prior therapies (1-12)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, evaluated per RECIST and CA125
Biomarkers	Exploratory: CDKN2A, RB1 and CCNE1
Efficacy	RECIST criteria: ORR: 6% (2 PR, n=35); DCR: 49% (2PR, 15SD, n=35); PFS: 3.1 months (2.2-4.0) CA125 criteria: ORR: 13% (2CR, 3 PR, n=40); DCR: 65% (2CR, 3PR, 21SD, n=40); PFS: 4.0 months (0.3-7.6) Exploratory analysis; NGS: 6 patients w/ response by CA125 or RECIST: 1 w/ CDKN2A loss, 1 w/CDKN2A loss and CCNE AMP, 1 w/ CDK6 AMP, NRAS AMP, BRAF AMP
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: neutropenia (13.5%), thrombocytopenia (10.8%)
Conclusion	Single agent activity in patients with p16 low tumors
Reference	Konecny G et al. 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. J Clin Oncol (2016) 34 (suppl; abstr 5557) https://ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.5557 Konecny G et al. Poster https://www.clearityfoundation.org/wp-content/uploads/2021/06/Palbociclib-in-ovarian-ASCO-2016-scaled.jpeg