This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors

Phase 1, Open Label, Dose-Escalation, Safety, Pharmacokinetic And Pharmacodynamic Study Of Single Agent PF-03758309, An Oral PAK4 Inhibitor, In Patients With Advanced Solid Tumors

This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients. The study will assess the compound's safety, the blood levels of PF-03758309 during the treatment and the effect of the compound on the tumor cells.

The study was prematurely terminated on 26Jul2011 due to the undesirable PK characteristics of PF-03758309 and the lack of an observed dose-response relationship. There were no safety concerns that contributed to the study termination.

Inclusion Criteria:

• Advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
• ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) must be 0 or 1.
• Adequate bone marrow, liver and kidney function.

Exclusion Criteria:

• Patients with known brain metastases.
• Previous high dose chemotherapy requiring stem cell rescue.
• Prior irradiation to >25% of the bone marrow.
• Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV).
• Current active treatment in another clinical study.
• Pregnancy or breast feeding.
• Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.