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

Sponsor
University of Colorado, Denver (Other)
Overall Status
No longer available
CT.gov ID
NCT02955446
Collaborator
SpringWorks Therapeutics, Inc. (Industry)
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 101 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • SpringWorks Therapeutics, Inc.

    Investigators

    • Principal Investigator: Wells Messersmith, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02955446
    Other Study ID Numbers:
    • 15-2088.cc
    First Posted:
    Nov 4, 2016
    Last Update Posted:
    Feb 1, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by University of Colorado, Denver
    Refractory Tumors
    Advanced Solid Tumors
    Additional relevant MeSH terms:
    Fibromatosis, Aggressive

    Study Results

    No Results Posted as of Feb 1, 2019