An Investigation of TAS-119 Monotherapy

NCT02448589 | Terminated Phase 1 DMC

• 2 other identifiers: TAS-119-1022014-001272-63
• Study Type: interventional
• Target: 74
• Locations: 5 countries
• Sites: 6

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; Dose Escalation; Dose Expansion; MTD; TAS-119; Aurora A Kinase Inhibitor

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of TAS-119

  Up to 2.5 Years

Study Arms (1)

TAS-119 Monotherapy

EXPERIMENTAL

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)

Drug: TAS-119

Interventions

TAS-119 DRUG

TAS-119 Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a male or female, ≥ 18 years of age, who has provided written informed consent.
• Has histologically or cytologically confirmed advanced, unresectable, metastatic solid tumor(s) for which the patients have no available therapy likely to provide clinical benefit.
• Must have an archival FFPE tumor sample available, to be provided to the Sponsor upon request.
• In the Expansion Phase: patients should be willing to undergo tumor core biopsy procedure at pre-treatment and on Day 4, Cycle 1 if, in the judgment of the investigator, it is considered clinically safe and appropriate to do so. This requirement is optional but preferred for patients in Dose Escalation.
• Has adequate organ function.
• Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females and must agree to use effective birth control during the study if conception is possible during this interval.

You may not qualify if:

• Has received prior treatment with TAS-119.
• Has received treatment with any proscribed treatments within specified time frames prior to study drug administration.
• Has a serious illness or medical condition(s).

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (6)

University Hospitals - Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Erasmus MC Cancer Institute

Rotterdam, 3015CE, Netherlands

Location

START MADRID-FJD, Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

START Madrid Unidad de Ensayos Fase I

Madrid, 28050, Spain

Location

The Institute of Cancer Research

Sutton, Surrey, SM2 5NG, United Kingdom

Location

Related Publications (20)

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MeSH Terms

Interventions

TAS-119

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 19, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 4, 2024

Record last verified: 2024-08

Locations

IT (1); NL (1); ES (2); US (1); GB (1)