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

• Conditions: Neoplasm; Desmoid Tumor

• Registration Number: NCT02955446
• Lead Sponsor: University of Colorado, Denver

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

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States