NCT02955446

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

First QC Date

November 2, 2016

Last Update Submit

January 30, 2019

Conditions

NeoplasmDesmoid Tumor

Keywords

Refractory TumorsAdvanced Solid Tumors

Interventions

PF-03084014DRUG

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.

Also known as: Gamma Secretase Inhibitor

Eligibility Criteria

Age16 Years - 101 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients who are currently enrolled in A8641014 for \> 1 year are eligible

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

NeoplasmsDesmoid Tumors

Interventions

nirogacestat

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Wells Messersmith, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 4, 2016

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

US(1)