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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Pfizer

Criteria

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.