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

• Status: Withdrawn
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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