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Clinical trial with TAS-117 in patients with advanced solid tumors with germline inactivating mutations of the PTEN gene
THIS TRIAL CONSISTS OF TWO PARTS. THE PURPOSE OF PART A OF THIS TRIAL IS TO IDENTIFY AN OPTIMAL DOSE AND DOSING SCHEDULE FOR STUDY DRUG ADMINISTRATION FOR PART B, WHICH HAS ALREADY BEEN COMPLETED IN OTHER REGIONS. THE PURPOSE OF PART B IS TO EVALUATE THE EFFICACY OF TAS-117 IN SUBJECTS WHO HAVE ANY ADVANCED CANCER (EXCEPT BRAIN CANCER) WITH GERMLINE MUTATION OF THE PTEN GENE, TO UNDERSTAND WHETHER TAS-117 CAN STOP THE GROWTH OF THEIR CANCER OR SLOW ITS GROWTH. IN ADDITION, PART B WILL EVALUATE THE PHARMACOKINETICS AND PHARMACODYNAMICS OF TAS-117.
Technical Summary
- ESTUDIO DE FASE II DE TAS-117 EN PACIENTES CON TUMORES SÓLIDOS AVANZADOS QUE PRESENTAN MUTACIONES GERMINALES INACTIVADORAS DEL GEN PTEN
- Code EudraCT: 2020-004770-22
- Protocol number: TAS-117-201
- Promoter: Taiho Oncology, Inc.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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