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

Primary Purpose

Neoplasm, Desmoid Tumor

Status

No longer available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

PF-03084014

About this trial

This is an expanded access trial for Neoplasm focused on measuring Refractory Tumors, Advanced Solid Tumors

Eligibility Criteria

16 Years - 101 Years (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

University of Colorado

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT02955446

First Posted

November 2, 2016

Last Updated

January 30, 2019

Sponsor

University of Colorado, Denver

Collaborators

SpringWorks Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02955446

Brief Title

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

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

No longer available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

SpringWorks Therapeutics, Inc.

4. Oversight

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasm, Desmoid Tumor

Keywords

Refractory Tumors, Advanced Solid Tumors

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

PF-03084014

Other Intervention Name(s)

Gamma Secretase Inhibitor

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

101 Years

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wells Messersmith, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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