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


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, evaluated per RECIST and CA125


Exploratory: CDKN2A, RB1 and CCNE1


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%)


Single agent activity in patients with p16 low tumors


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)

Konecny G et al. Poster

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