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

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ClinicalTrials.gov Identifier: NCT02955446
Expanded Access Status : No longer available
First Posted : November 4, 2016
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Pfizer
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

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

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Ages Eligible for Study:   16 Years to 101 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02955446


Locations
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Pfizer
Investigators
Principal Investigator: Wells Messersmith, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02955446     History of Changes
Other Study ID Numbers: 15-2088.cc
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by University of Colorado, Denver:
Refractory Tumors
Advanced Solid Tumors

Additional relevant MeSH terms:
Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms