COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT02955446
Expanded Access Status : No longer available
First Posted : November 4, 2016
Last Update Posted : February 1, 2019
SpringWorks Therapeutics, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Neoplasm Desmoid Tumor Drug: PF-03084014

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

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
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

Intervention Details:
  • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 101 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02955446

Layout table for location information
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
SpringWorks Therapeutics, Inc.
Layout table for investigator information
Principal Investigator: Wells Messersmith, MD University of Colorado, Denver
Layout table for additonal information
Responsible Party: University of Colorado, Denver Identifier: NCT02955446    
Other Study ID Numbers:
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by University of Colorado, Denver:
Refractory Tumors
Advanced Solid Tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromatosis, Aggressive
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type