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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT02955446
Other study ID # 15-2088.cc
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date January 2019
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


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


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 16 Years to 101 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Colorado Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver SpringWorks Therapeutics

Country where clinical trial is conducted

United States, 

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