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

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02955446
First Posted: November 4, 2016
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Colorado, Denver
November 2, 2016
November 4, 2016
June 20, 2017
 
Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies
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
Expanded Access
, Treatment IND/Protocol
Drug: PF-03084014
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.
Other Name: Gamma Secretase Inhibitor
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02955446
University of Colorado, Denver
University of Colorado, Denver
Pfizer
Principal Investigator: Wells Messersmith, MD University of Colorado, Denver
University of Colorado, Denver
June 2017