An Investigation of TAS-119 Monotherapy

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: TAS-119

• Registration Number: NCT02448589
• Lead Sponsor: Taiho Oncology, Inc.

Brief Summary

A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.

Detailed Description

This is a Phase 1, open-label, non-randomized, dose escalation study of TAS-119 evaluating the safety, tolerability, PK, pharmacogenomics, pharmacodynamics, and preliminary antitumour activity in patients with advanced and unresectable solid tumours. The study will evaluate TAS-119 monotherapy, employing two sequential phases.

* A Dose Escalation Phase

* An Expansion Phase

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2020-02
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAS-119 Monotherapy	TAS-119	Dose Escalation: A Monotherapy Dose-Escalation Phase Performed in Approximately 5 Dose Levels (3 to 12 Patients Per Dose Level) to Determine the MTD for TAS-119 Given Orally (PO), Twice-Daily (BID) in a 28-Day Treatment Cycle; and: Dose Expansion: A Monotherapy Expansion Phase in Which Approximately 40 Additional Patients will be Enrolled to Further Evaluate the Recommended Phase II Dose (RP2D)

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	Up to 2.5 Years	Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of TAS-119

Trial Locations

Locations (6)

University Hospitals - Seidman Cancer Center; 🇺🇸 Cleveland, Ohio, United States

San Raffaele Hospital; 🇮🇹 Milano, Italy

START MADRID-FJD, Hospital Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

The Institute of Cancer Research; 🇬🇧 Sutton, Surrey, United Kingdom

START Madrid Unidad de Ensayos Fase I; 🇪🇸 Madrid, Spain

Erasmus MC Cancer Institute; 🇳🇱 Rotterdam, Netherlands