Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies

Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies: Continuing Study Drug Administration in Desmoid Patients Receiving Clinical Benefit

This is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumor malignancies who were previously enrolled in the phase I study (NCT00878189) of this agent.

This is an expanded access-physician sponsored trial of PF-03084014, a novel gamma-secretase inhibitor being developed for cancer therapy. This trial is designed for patients who have been on a previous Industry-sponsored phase I trial using PF-03084014 for> 1 year. The study is designed to evaluate the safety of prolonged oral administration of single agent PF-03084014. There are two study subjects with desmoid tumor who have been on the trial for a prolonged period of time (54 and 77 months, respectively) with either stable disease or response, indicating significant clinical benefit for a patient population in which there are few options. The goal of this protocol is to allow these subjects, who are clearly benefiting from PF-03084014, to continue to receive it

Inclusion Criteria:

- Patients who are currently enrolled in A8641014 for > 1 year are eligible

Exclusion Criteria:

• Prior treatment with a gamma secretase inhibitor for treatment of cancer
• Patients taking Tamoxifen
• Patients with active graft versus host disease
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
• Patients who are pregnant or breast-feeding
• Patients with clinical evidence of central nervous system disease