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

Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies: Continuing Study Drug Administration in Desmoid Patients Receiving Clinical Benefit

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02955446
Enrollment
Unknown
Registered
2016-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desmoid Tumor, Neoplasm

Keywords

Refractory Tumors, Advanced Solid Tumors

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

Interventions

DRUGPF-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.

Sponsors

SpringWorks Therapeutics, Inc.
CollaboratorINDUSTRY
University of Colorado, Denver
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
16 Years to 101 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026