A Phase 1 Study Of The Safety And Pharmacokinetics Of Oral PD-0332991, A Cyclin-Dependent Kinase 4 And 6 (CDK4/6) Inhibitor, In Japanese Patients With Advanced Solid Tumors
- In Part 1, advanced solid tumor (except SCLC or retinoblastoma) proven histologically
or cytologically at original diagnosis, that is refractory to standard therapy or for
whom no standard of care therapy is available.
- In Part 2, post menopausal women with proven diagnosis of ER-positive, HER2-negative
adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic
disease (including bone only disease) not amenable to resection or radiation therapy
with curative intent and for whom chemotherapy is not clinically indicated.
- Adequate blood cell counts, kidney function and liver function and and Eastern
Cooperative Oncology Group [ECOG] score of 0 or 1.
- Resolved acute effects of any prior therapy to baseline severity or Grade ≤1
- Active uncontrolled or symptomatic CNS metastases.
- Uncontrolled infection, unstable or sever intercurrent medical condition, or current
drug or alcohol abuse
- Active or unstable cardiac disease or history of heart attack within 6 months