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

Brief Summary: 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.

Detailed Description: 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

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Locations (1): University of Colorado
🇺🇸
Aurora, Colorado, United States
University of Colorado
🇺🇸Aurora, Colorado, United States