TAS-117 in Tumors Harboring Germline PTEN Inactivating Mutations

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This study involves taking a study drug called TAS-117. The overall goal of this study is to see if TAS-117 is a possible treatment for advanced cancers with germline mutations in the PTEN gene.

Eligibility & Criteria

IRB #:
21-018783
Official Title:
A Phase 2 Study of TAS-117 in Patients with Advanced Solid Tumors Harboring Germline PTEN Inactivating Mutations
Study Phase:
Phase I
Eligible Age Range:
12 - 30 Years
Gender:
All
Study Categories:

Visit Criteria

This study will enroll male and female patients between 12 and 30 years of age that have been diagnosed with germline mutations in a gene called PTEN and have already received all possible treatments.  Subjects will receive TAS-117, which is an oral medication. The treatment will be divided into separate 21-day periods called cycles and the duration of each subject will depend treatment response. Study visits include the following assessments: blood draws (to confirm eligibility and for other research tests), electrocardiograms (ECGs), and the collection of extra tissue if a tumor biopsy is performed as part of regular clinical care. Subjects will also be asked to complete questionnaires about their pain symptoms, the severity of their disease, and their quality of life.