Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid TumorMalignancies
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This is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumormalignancies who were previously enrolled in the phase I study (NCT00878189) of this agent.
Condition or disease
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
Two patients enrolled in this study will continue receiving 80mg BID doses of PF-03084014, which was the same dose/schedule of their latest cycle on protocol A8641014. PF-03084014 will be administered twice a day in the morning and evening divided by approximately 12 hours. PF-03084014 should be administered in cycles of 21 days continuously.
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Ages Eligible for Study:
16 Years to 101 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
- Patients who are currently enrolled in A8641014 for > 1 year are eligible
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