A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors

Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors

The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.

Inclusion Criteria:

• Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available.
• Age ≥18 years.
• ECOG Performance Status (PS) must be 0 or 1.
• Adequate Bone Marrow Function
• Adequate Renal Function
• Adequate Liver Function
• Resolved acute effects of any prior therapy to baseline severity or Grade ≤1

Exclusion Criteria:

• Patients with known brain metastases
• Major surgery within 4 weeks of starting study treatment
• Radiation therapy within 2 weeks of starting study treatment
• Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment
• Previous high dose chemotherapy requiring stem cell rescue
• Prior irradiation to >25% of the bone marrow
• Prior treatment with a Notch signal inhibitor
• Known malabsorption syndrome or other condition that may impair absorption of study medication
• Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
• Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors
• Current use or anticipated need for known strong CYP3A4 inducers